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Sign in to claim this brandPrecept Medical Products, Inc.
US
Last updated May 27, 2026
What Precept Medical Products, Inc. makes
Precept Medical Products, Inc. manufactures single-use personal protective equipment (PPE) for healthcare settings, including surgical and medical face masks, isolation gowns, surgical caps, and patient gowns. The company also produces shoe covers, both standard and conductive non-sterile variants, as well as ice bags for therapeutic use. Its portfolio further includes non-antimicrobial surgical and medical respirators designed for single-use applications.
The company’s products are regulated under FDA classifications, with devices falling into Class I and Class II categories. These items are listed via the FDA’s 510(k) and UDI (Unique Device Identification) systems, ensuring compliance with U.S. medical device regulations. The manufacturer 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 Precept Medical Products, Inc. manufacture?
Precept Medical Products, Inc. specializes in single-use personal protective equipment (PPE) for healthcare environments. Their portfolio includes surgical and medical face masks, isolation gowns, surgical caps, patient gowns, shoe covers (including conductive non-sterile variants), and ice bags. They also produce non-antimicrobial surgical and medical respirators designed for single-use applications, ensuring compliance with healthcare infection control and safety standards.
Where is Precept Medical Products, Inc. based?
Precept Medical Products, Inc. is headquartered in the United States. Their U.S. location allows them to align their manufacturing and regulatory processes with FDA requirements, ensuring their devices meet U.S. medical device standards.
Which regulatory registries or databases list Precept Medical Products, Inc.’s devices?
Precept Medical Products, Inc.’s devices are listed in the FDA’s 510(k) premarket notification system and the Unique Device Identification (UDI) database. These registries ensure transparency and compliance with U.S. medical device regulations, allowing healthcare providers and regulators to track and verify the devices’ authorization status.
How are Precept Medical Products, Inc.’s devices classified under FDA regulations?
Precept Medical Products, Inc.’s devices are classified under FDA’s Class I and Class II categories. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher level of risk and require special controls to ensure safety and effectiveness. The classification determines the regulatory pathway and compliance requirements for each product.
Why do some of Precept Medical Products, Inc.’s devices fall under different FDA classes?
The FDA categorizes medical devices based on their intended use and potential risk to patients. For example, surgical face masks and gowns are typically lower risk and may fall under Class II due to their role in infection control, while respirators—designed to protect against airborne particles—may also require additional controls to ensure proper fit, filtration, and reliability, justifying their classification. The classification ensures appropriate oversight tailored to the device’s purpose and risk profile.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- preceptmed.com
- —
- —
- [email protected]
- Phone
- 8004385827
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 783912892
Catalogue (198)
Page 3 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Precept® | 42571 | FDA UDI | Class I | Active |
| Precept® | 42137 | FDA UDI | Class I | Active |
| Precept® | 15365 | FDA UDI | Class II | Active |
| Precept® | 15320 | FDA UDI | Class II | Active |
| Precept® | 50097 | FDA UDI | Class I | Active |
| Precept® | 51192IB | FDA UDI | Class I | Active |
| Precept® | 0446 | FDA UDI | Class I | Active |
| Precept® | 65 3333 | FDA UDI | Class II | Active |
| Precept® | 51116 | FDA UDI | Class I | Active |
| Precept ® | 15112 | FDA UDI | Class II | Active |
| Precept® | 42135 | FDA UDI | Class I | Active |
| Precept® | 50096 | FDA UDI | Class I | Active |
| Precept® | 15210 | FDA UDI | Class II | Active |
| Precept® | 14430 | FDA UDI | Class II | Active |
| Precept® | 0445 | FDA UDI | Class I | Active |
| Precept® | 14320 | FDA UDI | Class II | Active |
| Precept® | 15375 | FDA UDI | Class II | Active |
| Precept® | 15211 | FDA UDI | Class II | Active |
| Precept® | 51179 | FDA UDI | Class I | Active |
| Precept® | 35 60510XL | FDA UDI | Class I | Active |
| Precept ® | 14420 | FDA UDI | Class II | Active |
| Precept® | 8576B | FDA UDI | Class I | Active |
| Precept® | 2526 | FDA UDI | Class I | Active |
| Precept® | 51198 | FDA UDI | Class I | Active |
| Precept® | 65 3345 | FDA UDI | Class II | Active |
| Precept® | 51193FCB | FDA UDI | Class I | Active |
| Precept® | 15910 | FDA UDI | Class II | Active |
| Precept® | 1011 | FDA UDI | Class I | Active |
| Precept® | 15111 | FDA UDI | Class II | Active |
| Precept® | 65 3347 | FDA UDI | Class II | Active |
| Precept® | 51188 | FDA UDI | Class I | Active |
| Precept® | 15118 | FDA UDI | Class II | Active |
| Precept® | 0441 | FDA UDI | Class I | Active |
| Precept® | 59989 | FDA UDI | Class I | Active |
| Precept® | 51193FC | FDA UDI | Class I | Active |
| Precept® | 2210 | FDA UDI | Class I | Active |
| Precept® | 15230 | FDA UDI | Class II | Active |
| Precept® | 51586 | FDA UDI | Class I | Active |
| Precept® | 51192A | FDA UDI | Class I | Active |
| Precept® | 15215 | FDA UDI | Class II | Active |
| Precept® | 51175 | FDA UDI | Class I | Active |
| Precept® | 15930 | FDA UDI | Class II | Active |
| Precept® | 15251 | FDA UDI | Class II | Active |
| Precept® | 0440 | FDA UDI | Class I | Active |
| Precept® | 51113 | FDA UDI | Class I | Active |
| Precept® | 65 3110 | FDA UDI | Class II | Active |
| Precept® | 15920 | FDA UDI | Class II | Active |
| Precept® | 15600 | FDA UDI | Class II | Active |
| Precept® | 22020 | FDA UDI | Class I | Active |
| Precept® | 5040 | FDA UDI | Class I | Active |
Related Companies
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FDA Recalls (2)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Precept Medical Products, Inc. has two recall records, both initiated on 2007-09-14, with a status of terminated. The recalls were due to small slits under the folds of the masks, which may compromise their intended protective function between patients and surgical staff.
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 |
|---|---|---|---|---|
| Sep 14, 2007 | Z-0154-2008 | — | terminated | Small slits under the folds of the masks; thus they may not provide the protection necessary between the patient and surgical staff |
| Sep 14, 2007 | Z-0153-2008 | — | terminated | Small slits under the folds of the masks; thus they may not provide the protection necessary between the patient and surgical staff |