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QUEST MEDICAL INC

Last updated May 24, 2026

What QUEST MEDICAL INC makes

Quest Medical Inc manufactures intravenous administration tubing extension sets, reusable cardiopulmonary bypass system heat exchangers, and cardioplegia solution administration kits. The company also produces single-use aorta punches, non-bioabsorbable surgical support tape, unidirectional flow and pressure control valves for cardiopulmonary bypass systems, lacrimal intubation sets, and stopcocks.

The company is based in the United States, and its product portfolio includes devices categorized as Class I, Class II, and Class U. These devices are listed in the FDA 510(k) and FDA UDI databases.

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

Frequently asked questions

Where is Quest Medical Inc based?

Quest Medical Inc is based in the United States. This information is provided to clarify the company's geographical origin and operational base as stated in the official device data.

What types of medical devices does Quest Medical Inc manufacture?

The company manufactures a diverse range of medical equipment, including intravenous administration tubing extension sets, reusable cardiopulmonary bypass system heat exchangers, and cardioplegia solution administration kits. Additionally, they produce single-use aorta punches, non-bioabsorbable surgical support tape, unidirectional flow and pressure control valves for cardiopulmonary bypass systems, lacrimal intubation sets, and stopcocks.

How are the devices from Quest Medical Inc classified?

The devices produced by Quest Medical Inc are classified as Class I, Class II, and Class U. These classifications are assigned based on the regulatory framework governing the specific medical devices within the company's portfolio.

Which regulatory registries list the devices produced by Quest Medical Inc?

The devices manufactured by Quest Medical Inc are listed in the FDA 510(k) and FDA UDI databases. These registries are used to track and document the regulatory status and identification of the medical devices produced by the company.

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

Information

Country: US
Address: —
Website: questmedical.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 1-800-627-0226
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 041810693

Catalogue (311)

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Device	Model / Reference	Registries	Class	Status
MPS Console Adapter Plate	5001027	FDA UDI	Class II	Active
Checkmate Extension Set 36 inch (91cm)	9657	FDA UDI	Class II	Active
Precision Delivery Bifurcated IV Extension Set	PDBV05F	FDA UDI	Class II	Active
CleanCut Rotating Aortic Punch	RCL48	FDA UDI	Class I	Active
RLV-T Suction Control Device_Nonsterile	4103205	FDA UDI	Class II	Active
Aortic Root Transducer Interface Cable (Antegrade)	511800A	FDA UDI	Class II	Active
RLV-T Suction Control Device	4103105	FDA UDI	Class II	Active
Retract-o-Tape 16g x 45.8cm Thin Wall_nonsterile	1212	FDA UDI	Class I	Active
Precision Delivery Trifurcated IV Extension Set	PDT05DF	FDA UDI	Class II	Active
Exoflex 53in. T-Extension Set	95789	FDA UDI	Class II	Active
Precision Delivery Trifurcated IV Extension Set	PDTV05F	FDA UDI	Class II	Active
CleanCut 4.8 mm Nonsterile Bullet Aortic Punch	RCB48BNS	FDA UDI	Class I	Active
MPS Power Cord, North America, Refurbished	520NA16E	FDA UDI	Class II	Active
MPS® Extension Tubing, 6 ft. x 1/8 in.	7001104	FDA UDI	Class II	Active
VRV-IIC Clear Vacuum Relief Valve	4004103	FDA UDI	Class II	Active
Vessel Cannula, 3mm	VCC-03	FDA UDI	Class II	Active
MPS 3 Delivery Set w/AA w/305cm Line	5003102	FDA UDI	Class II	Active
Precision Delivery IV Extension Set	PD06F	FDA UDI	Class II	Active
Precision Delivery Trifurcated IV Extension Set	PDTV05DF	FDA UDI	Class II	Active
Precision Delivery IV Extension Set	PDV60	FDA UDI	Class II	Active
Q2 IV Administration Set	ASV10130	FDA UDI	Class II	Active
Q2 High Flow Stopcock	STV01	FDA UDI	Class II	Active
Quest Coronary Sinus Perfusion Cannula	K941166	FDA 510(k)	Class II	Active
Injection Site, Code No. 3100	K800786	FDA 510(k)	Class II	Active
Syringe Additive Iv Admin. Sets	K841361	FDA 510(k)	Class II	Active
Multiport Manifold Set With Swabable Valves, Model 9900	K040385	FDA 510(k)	Class II	Active
Quest Vein Graft Perfusion Set	K952531	FDA 510(k)	Class II	Active
Quest Vessel Catheter	K971928	FDA 510(k)	Class II	Active
Swabsite Swabbable Valve, Model 245000	K002689	FDA 510(k)	Class II	Active
Nitroglycerin Intravascular Administration Set	K860157	FDA 510(k)	Class II	Active
Quest Antegrade Cardioplegia Cannula	K950814	FDA 510(k)	Class II	Active
Q2 Blood Administration Sets	K213846	FDA 510(k)	Class II	Active
Foamseal Retrograde Cardioplegia Catheter	K955818	FDA 510(k)	Class II	Active
Model 2001 Intelligent Infusor	K834528	FDA 510(k)	Class II	Active
Precision Delivery Infusion Set	K202672	FDA 510(k)	Class II	Active
Stentube Lacrimal Intubation Set	K113118	FDA 510(k)	U	Active
Liposol	K830472	FDA 510(k)	Class II	Active
Quest Coronary Sinus Perfusion Cannula -frcc	K941916	FDA 510(k)	Class II	Active
MPS2 Myocardial Protection System Console	K173716	FDA 510(k)	Class II	Active
Quest Retrograde Cardiplegia Cannula-Rccs	K951088	FDA 510(k)	Class II	Active
Q2 Multiport IV Administration Sets and Extension Sets, Checkmate Multiport IV Administration Sets, Q2 Extension Sets	K162304	FDA 510(k)	Class II	Active
Quest Mps Perfusion Assisted Direct Coronary Artery Bypass (padcab)	K994274	FDA 510(k)	Class II	Active
Q2 Low Pressure Power Injection Extension Set	K162804	FDA 510(k)	Class II	Active
Q2 Intravenous Adminstration Sets and Extension Sets	K151079	FDA 510(k)	Class II	Active
Myocardial Protection System	K953838	FDA 510(k)	Class II	Active
Volumeric Controller	K823404	FDA 510(k)	Class II	Active
Catheter Guide Wire	K820699	FDA 510(k)	Class II	Active
Quest Mps Back-Up Sysyem	K002366	FDA 510(k)	Class II	Active
Silicone Elastomer Infusion Catheter	K813606	FDA 510(k)	Class I	Active
Quest 521 Variable Pressure Volumetric Infusion Pu	K851017	FDA 510(k)	Class II	Active

Related Companies

Authorised Representatives

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Importers

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Authorities

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FDA Recalls (7)

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

Quest Medical Inc has seven recall records, with the earliest initiated on 2003-05-23 and the most recent on 2023-07-14. The recorded statuses include open, classified, and terminated. The reasons listed for the recalls involve swapped and incorrectly placed additive and arrest agent labels on a heat exchanger kit, potential tubing detachment in delivery sets, an incorrectly printed expiration date on pouch and carton labels, a user update concerning installation of external heater‑cooler units, intermittent seal failure during use, and cassette leaks that could delay administration of cardioplegia solutions.

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
Jul 14, 2023	Z-0197-2024	—	open, classified	For administration of intravenous fluids to a patient s vascular system utilizing needle-free components and I.V. manifold for multiple simultaneous intravenous therapy via gravity, syringe, or infusion pump. Use of a needle-free system may aid in the prevention of needle-stick injuries.
Dec 23, 2022	Z-1100-2023	—	open, classified	Delivery Sets may have tubing that could become detached that could result in patient infection.
Dec 17, 2019	Z-2107-2020	—	terminated	Additive and Arrest Agent Labels on the MPS Top Cover Replacement Kit, a replacement for worn or damaged MPS Console Top Covers for cardiopulmonary bypass heat exchanger, used to deliver whole blood to the heart during open heart surgery, were swapped and incorrectly placed. This could lead to over delivery of potassium by the user requiring medical intervention.
Oct 28, 2015	Z-0361-2016	—	terminated	The products have been found to intermittently exhibit a seal failure during use.
Feb 26, 2015	Z-1368-2015	—	terminated	Expiration date incorrectly printed in Manufacturing Date field on both pouch and carton labels
Jul 29, 2010	Z-1924-2011	—	terminated	User update regarding installation of external heater-Cooler units with MPS and MPS2 consoles.
May 23, 2003	Z-1037-03	—	terminated	Cassettes leak causing a delay of administration of cardioplegia solutions to the heart during open heart surgery.