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Sechrist Industries Inc

United States·US-MF-000017869

Last updated May 27, 2026

What Sechrist Industries Inc makes

The company manufactures stationary hyperbaric chambers for medical oxygen therapy, along with hospital-grade oxygen and air breathing gas mixers. It also produces neonatal intensive-care ventilators, reusable electrical connection cables for medical devices, and various reusable respiratory valves, including demand and non-rebreathing types. Orthopaedic and manual hospital stretchers are part of its portfolio, designed for patient transport and clinical use.

The portfolio includes devices classified as Class I, Class II, Class IIa, and Class IIb under regulatory frameworks. Products are listed in the EU’s eudamed database, the FDA’s 510(k) premarket notification registry, and the FDA’s Unique Device Identifier (UDI) database. The company is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Sechrist Industries Inc manufacture?

Sechrist Industries Inc specializes in a range of medical devices primarily used in critical care, respiratory therapy, and patient transport. Their portfolio includes stationary hyperbaric chambers for oxygen therapy, hospital-grade oxygen and air breathing gas mixers, neonatal intensive-care ventilators, and reusable respiratory components like demand valves and non-rebreathing valves. Additionally, they produce reusable electrical connection cables for medical devices and both orthopaedic and manual hospital stretchers for patient mobility and clinical use.

Where is Sechrist Industries Inc based, and what regulatory frameworks apply to their devices?

Sechrist Industries Inc is based in the United States. Their devices fall under various regulatory classifications, including Class I, Class II, Class IIa, and Class IIb, depending on the product’s risk level and intended use. These classifications determine the regulatory pathway for authorization, such as FDA’s 510(k) premarket notification for higher-risk devices like ventilators or hyperbaric chambers, while lower-risk items may qualify for Class I exemptions.

Which regulatory registries list Sechrist Industries Inc’s devices?

Sechrist Industries Inc’s devices are listed in multiple global regulatory databases to ensure traceability and compliance. Their products appear in the EU’s eudamed database, the FDA’s 510(k) premarket notification registry (for higher-risk devices), and the FDA’s Unique Device Identifier (UDI) database, which standardizes identification for medical devices in the U.S. market.

How are Sechrist Industries Inc’s devices classified under regulatory standards?

Sechrist Industries Inc’s devices are categorized into different regulatory classes based on their risk level and purpose. For example, neonatal ventilators and hyperbaric chambers are typically classified as Class IIb due to their critical function and associated risks, requiring stricter premarket evaluation. In contrast, reusable connection cables or non-rebreathing valves may fall under Class I or IIa, depending on their design and potential hazards, which often simplifies regulatory requirements.

Why might a hospital or healthcare provider need to check Sechrist Industries Inc’s device listings?

Healthcare providers should verify Sechrist Industries Inc’s device listings to confirm compliance, traceability, and proper classification for their intended use. For instance, checking the FDA’s 510(k) registry ensures that high-risk devices like ventilators meet U.S. safety standards, while reviewing eudamed helps verify EU-market compliance. The UDI database also aids in inventory management and recall tracking, ensuring only authorized and properly identified devices are used in patient care.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: United States
Address: 4225, E La Palma Ave, Anaheim, United States
Website: www.sechristusa.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 714-579-8400
PRRC Contact: Kim Duong
EUDAMED SRN: US-MF-000017869
FDA FEI Number: —
DUNS Number: 062084215

Catalogue (207)

Page 4 of 5

Device	Model / Reference	Registries	Class	Status
Sechrist Industries, Inc.	20409-3	FDA UDI	Class II	Active
Sechrist Industries, Inc.	2800R	FDA UDI	Class II	Active
Sechrist Industries, Inc.	3500CP-G14	FDA UDI	Class II	Active
Sechrist Industries, Inc.	21762-111-36H	FDA UDI	Class II	Unknown
Sechrist Industries, Inc.	20090	FDA UDI	Class II	Active
Sechrist Industries, Inc.	3500CP-G17	FDA UDI	Class II	Active
Sechrist Industries, Inc.	21790-111	FDA UDI	Class II	Active
Sechrist Industries, Inc.	3600H-01-0	FDA UDI	Class II	Active
Sechrist Industries, Inc.	21790-021	FDA UDI	Class II	Active
Sechrist Industries, Inc.	3300HRP-00-0	FDA UDI	Class II	Active
Sechrist Industries, Inc.	3300HP-01-1	FDA UDI	Class II	Active
Sechrist Industries, Inc.	3500CP-G4	FDA UDI	Class II	Active
Sechrist Industries, Inc.	4100H-00-1	FDA UDI	Class II	Active
Sechrist Industries, Inc.	22192-1	FDA UDI	Class II	Active
Sechrist Industries, Inc.	21762-111	FDA UDI	Class II	Unknown
Sechrist Industries, Inc.	20457-9	FDA UDI	Class II	Active
Sechrist Industries, Inc.	3300HR-H-00-0	FDA UDI	Class II	Active
Sechrist Monoplace Hyperbaric Chamber and Gurney	4100HR	EUDAMEDFDA UDI	Class IIb	Active
Electric Wheeled Stretcher EZ LOAD without Stretcher Plate, without mattress, English	20582-S-231	EUDAMEDFDA UDI	Class I	Active
Lsp Demand Inhalator Valve Model Spoo68 W/Mask	K884543	FDA 510(k)	Class II	Active
Sechrist Air-Oxygen Mixer, 3500/3500hl Series	K992503	FDA 510(k)	Class II	Active
Sechrist Airway Pressure Monitor Model 600	K861330	FDA 510(k)	Class II	Active
Sechrist Series 3500 Air-Oxygen Mixer	K802226	FDA 510(k)	Class II	Active
Model 2500e/2500er Hyperbaric Chamber	K934164	FDA 510(k)	Class II	Active
Volume Ventilator	K832508	FDA 510(k)	Class II	Active
Sechrist Volume Ventilator Modification	K850740	FDA 510(k)	N/A	Active
Sechrist Airway Pressure Monitor #400	K810648	FDA 510(k)	Class II	Active
Model 3200p/3200pr Hyperbaric Chamber	K950386	FDA 510(k)	Class II	Active
Model Iv 100b-Da Infant Ventilator	K833982	FDA 510(k)	Class II	Active
Sehrist Volume Ventilator, Model 2200b	K914607	FDA 510(k)	Class II	Active
Model 3300e/Er Monoplace Hyperbaric Oxygen Chamber	K052713	FDA 510(k)	Class II	Active
Infant Ventilator Model 100	K780188	FDA 510(k)	Class II	Active
The Infant Flow System	K930713	FDA 510(k)	Class I	Active
Sechrist Disposable Infant Breathing Circuit	K895853	FDA 510(k)	Class I	Active
Sechrist Monoplace Hyperbaric Oxygen Chamber	K140559	FDA 510(k)	Class II	Active
Sechrist Air/Oxygen Mixer, Model 3500 Cp-G	K023745	FDA 510(k)	Class II	Active
Sechrist Volume Ventilator Model 2200b	K896269	FDA 510(k)	Class II	Active
Sechrist Infant Ventrilator Model Iv-100	K811141	FDA 510(k)	Class II	Active
Millennium Infant Ventilator	K993167	FDA 510(k)	Class II	Active
Sechrist Model 990 Jet Ventilator	K821930	FDA 510(k)	Class II	Active
Sechrist Monoplace Hyperbaric Oxygen Chamber	K100268	FDA 510(k)	Class II	Active
Hyperbaric Intravenous Infusion Extension Set	K884156	FDA 510(k)	Class II	Active
Sechrist Air/Oxygen Gas Mixer	20459	EUDAMEDFDA UDI	Class IIa	Active
Electric Wheeled Stretcher Standard, Flat Narrow Mattress, English	20582-021	EUDAMEDFDA UDI	Class I	Active
Sechrist Air/Oxygen Gas Mixer	20457	EUDAMEDFDA UDI	Class IIa	Active
Sechrist Monoplace Hyperbaric Chamber and Gurney	3600HR	EUDAMEDFDA UDI	Class IIb	Active
Sechrist Air/Oxygen Gas Mixer	3600	EUDAMEDFDA UDI	Class IIa	Active
Sechrist Monoplace Hyperbaric Chamber and Gurney	3600H	EUDAMEDFDA UDI	Class IIb	Active
Sechrist Monoplace Hyperbaric Chamber and Gurney	4100H	EUDAMEDFDA UDI	Class IIb	Active
Electric Wheeled Stretcher with headrest, Bariatric Mattress, English	20582-111	EUDAMEDFDA UDI	Class I	Active

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FDA Recalls (10)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Sechrist Industries Inc. has ten recall records initiated between May 20, 2004, and June 1, 2015, all of which are recorded as terminated. The reasons cited include electronic malfunctions in manometers (potential illegibility or alarm failure), braking system issues (fractured bushings or cracked brake cams), unexpected height adjustments in stretchers, and a software bug in hyperbaric chamber control modules.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Jun 1, 2015	Z-1939-2015	—	terminated	Sechrist Industries is recalling the Sechrist Low Profile Wheeled Stretcher because it may experience an unexpected incline angle during the height adjustment of the Low Profile Wheeled Stretcher when lifting the patient upward or when lowering the Wheeled Stretcher to a height at which the patient can be loaded/unloaded.
Sep 15, 2009	Z-0816-2012	—	terminated	Stryker Medical has received complaints from customers that indicate a bushing in the braking system may fracture, which could result in the brake/steer pedal seizing. If the pedal seizes, the braking system may become inoperable or steering around corners may come more difficult. While no injuries have been associated with these reported events nor has there been reported failure events resulting
Aug 28, 2008	Z-0209-2013	—	terminated	Sechrist conducted a field upgrade on the hyperbaulic chambers equipped with Electronic Control Modules in order to correct a software bug that could potentially affect the performance of the chamber.
Aug 28, 2008	Z-0208-2013	—	terminated	Sechrist conducted a field upgrade on the hyperbaulic chambers equipped with Electronic Control Modules in order to correct a software bug that could potentially affect the performance of the chamber.
Oct 31, 2007	Z-0737-2008	—	terminated	Brake Problems: The stretcher brake cams may crack while attempting to lock the stretcher brake (Sechrist is supplied the stretchers by the manufacturer Stryker Medical)
Oct 31, 2007	Z-0736-2008	—	terminated	Brake Problems: The stretcher brake cams may crack while attempting to lock the stretcher brake (Sechrist is supplied the stretchers by the manufacturer Stryker Medical)
Oct 31, 2007	Z-0734-2008	—	terminated	Brake Problems: The stretcher brake cams may crack while attempting to lock the stretcher brake (Sechrist is supplied the stretchers by the manufacturer Stryker Medical)
Oct 31, 2007	Z-0733-2008	—	terminated	Brake Problems: The stretcher brake cams may crack while attempting to lock the stretcher brake (Sechrist is supplied the stretchers by the manufacturer Stryker Medical)
Oct 31, 2007	Z-0735-2008	—	terminated	Brake Problems: The stretcher brake cams may crack while attempting to lock the stretcher brake (Sechrist is supplied the stretchers by the manufacturer Stryker Medical)
May 20, 2004	Z-1032-04	—	terminated	Electronic manometer malfunctions. Manometer may be illegible. The alarm for power failure may function only briefly, or not at all.