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Sign in to claim this brandNidek Medical Products Inc.
United States·US-MF-000007253
Last updated May 30, 2026
What Nidek Medical Products Inc. makes
Nidek Medical Products Inc. manufactures stationary oxygen concentrators, including models like the MARK 5 NUVO series (8, 10, and Lite variants), which deliver concentrated oxygen for home or clinical use. The company also produces medical gas flowmeters with Thorpe tubes, such as the Penta Flow Oxygen Flow Splitter, designed for precise gas delivery in respiratory therapy.
The company’s devices are regulated under FDA 510(k) and UDI requirements in the US and listed in the EU’s eudamed registry. Products span Class I, Class II, and Class IIa/IIb classifications, depending on their intended use and risk level.
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 Nidek Medical Products Inc. manufacture?
Nidek Medical Products Inc. specializes in stationary oxygen concentrators and medical gas flowmeters. Their stationary oxygen concentrators, such as the MARK 5 NUVO series (including variants like NUVO 8, NUVO 10, and NUVO Lite), are designed to deliver concentrated oxygen for use in home or clinical settings. Additionally, the company produces medical gas flowmeters with Thorpe tubes, like the Penta Flow Oxygen Flow Splitter, which are used for precise gas delivery in respiratory therapy applications.
Where is Nidek Medical Products Inc. based?
Nidek Medical Products Inc. is based in the United States. The company’s headquarters and operations are located within the country, though specific regional offices or manufacturing sites may vary.
Which regulatory registries list Nidek Medical Products Inc.’s devices?
Nidek Medical Products Inc.’s devices are listed in multiple regulatory registries, including the European Union’s eudamed database and the US FDA’s 510(k) and UDI (Unique Device Identification) registries. These listings ensure transparency and compliance with regulatory requirements in both markets.
How are Nidek Medical Products Inc.’s devices classified under regulatory standards?
Nidek Medical Products Inc.’s devices are classified under different FDA categories depending on their intended use and associated risk levels. Their products fall into Class I, Class II, Class IIa, and Class IIb classifications. For example, simpler devices like certain flowmeters may qualify as Class I, while more complex or higher-risk oxygen concentrators may be classified as Class II or IIb, reflecting their regulatory oversight requirements.
Why do some of Nidek Medical Products Inc.’s devices appear multiple times in the example list?
The repeated examples in the list (such as multiple MARK 5 NUVO LITE entries) reflect variations in device models or configurations rather than distinct individual devices. These entries highlight the range of similar products within the same series, which may differ slightly in specifications (e.g., flow rates, power output, or intended clinical use) but share core functionality. The repetition underscores the breadth of options available within their product lines.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- United States
- Address
- 3949, Valley East Industrial Drive, Birmingham, United States
- Website
- www.nidekmedical.com
- —
- —
- [email protected]
- Phone
- 800-822-9255
- PRRC Contact
- Olivia Mullen
- EUDAMED SRN
- US-MF-000007253
- FDA FEI Number
- —
- DUNS Number
- 161382940
Catalogue (67)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Mark 5 Nuvo 8 | 585 | FDA UDI | Class II | Active |
| Mark 5 Nuvo 8 | 580 | FDA UDI | Class II | Active |
| Mark 5 Nuvo Lite | 925GCUK | FDA UDI | Class II | Active |
| Mark 5 Nuvo Lite | 920/60UK | FDA UDI | Class II | Active |
| Mark 5 Nuvo 8 | 985GCUK | FDA UDI | Class II | Active |
| Mark 5 Nuvo Lite | 525GC | FDA UDI | Class II | Active |
| Mark 5 Nuvo Lite | 920 | FDA UDI | Class II | Active |
| Penta Flow Oxygen Flow Splitter | 295 | FDA UDI | Class I | Active |
| Mark 5 Nuvo Lite | 925DP | FDA UDI | Class II | Active |
| Mark 5 Nuvo 10 | 595NSH | FDA UDI | Class II | Active |
| Mark 5 Nuvo Lite | 525M | FDA UDI | Class II | Active |
| Mark 5 Nuvo 8 | 980 | FDA UDI | Class II | Active |
| Mark 5 Nuvo Lite | 920UK | FDA UDI | Class II | Active |
| Mark 5 Nuvo Lite | 525NEB | FDA UDI | Class II | Active |
| Mark 5 Nuvo Lite | 925BMC | FDA UDI | Class II | Active |
| Mark 5 Nuvo 8 | 985GC | FDA UDI | Class II | Active |
| Mark 5 Nuvo Lite | 525CA | FDA UDI | Class II | Active |
| Mark 5 Nuvo Lite | 520 | FDA UDI | Class II | Active |
| Mark 5 Nuvo 8 | 580NSH | FDA UDI | Class II | Active |
| Mark 5 Nuvo 8 | 985NI | FDA UDI | Class II | Active |
| Mark 5 Nuvo 10 | 1005GC | FDA UDI | Class II | Active |
| Mark 5 Nuvo Lite | 925/60UK | FDA UDI | Class II | Active |
| Mark 5 Nuvo Lite | 520EX | FDA UDI | Class II | Active |
| Mark 5 Nuvo Lite | 520M | FDA UDI | Class II | Active |
| Mark 5 Nuvo Lite | 920NI | FDA UDI | Class II | Active |
| Mark 5 Nuvo Lite3 | 935/60 | FDA UDI | Class II | Active |
| Mark 5 Nuvo Lite | 525EX | FDA UDI | Class II | Active |
| Mark 5 Nuvo Lite | 525EXC | FDA UDI | Class II | Active |
| Mark 5 Nuvo Lite | 920NEB | FDA UDI | Class II | Active |
| Mark 5 Nuvo Lite | 525NFD | FDA UDI | Class II | Active |
| Mark 5 Nuvo 8 | 980UK | FDA UDI | Class II | Active |
| Mark 5 Nuvo Lite | 525 | FDA UDI | Class II | Active |
| Mark 5 Nuvo 8 | 985UK | FDA UDI | Class II | Active |
| Mark 5 Nuvo 10 | 1005GCUK | FDA UDI | Class II | Active |
| Mark 5 Nuvo Lite | 920/60 | FDA UDI | Class II | Active |
| Mark 5 Nuvo Lite3 | 935UK | FDA UDI | Class II | Active |
| Mark 5 Nuvo 10 | 1005NI | FDA UDI | Class II | Active |
| Mark 5 Nuvo 8 | 985DP | FDA UDI | Class II | Active |
| Mark 5 Nuvo Lite | 520EXE | FDA UDI | Class II | Active |
| Mark 5 Nuvo Lite | 925/60 | FDA UDI | Class II | Active |
| Mark 5 Nuvo Lite | 525IN | FDA UDI | Class II | Active |
| Mark 5 Nuvo 10 | 595 | FDA UDI | Class II | Active |
| Mark 5 Nuvo 8 | 980DP | FDA UDI | Class II | Active |
| Max 30 | 3005UK | EUDAMED | Class IIb | Active |
| Max 30 | 3005 | EUDAMED | Class IIb | Active |
| Cp-90 Continuous Positive Airway Pressure System | K952966 | FDA 510(k) | Class II | Active |
| Mark 5 Nuvo 8 Ocsi, Mark 5 Nuvo 8 Std | K093308 | FDA 510(k) | Class II | Active |
| Oxychek Oxygen Analyzer | K942593 | FDA 510(k) | Class II | Active |
| Pulmo-Mist Compressor Model # 4323 | K020797 | FDA 510(k) | Class II | Active |
| Mark 5 Nuvo (m5c5) | K032509 | FDA 510(k) | Class II | Active |
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FDA Recalls (9)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Nidek Medical Products Inc. has nine recall records, all initiated on 2012-05-01, with each listed as terminated. The sole reason cited across all records involves a potential capacitor failure that may create a fire hazard and loss of supplemental oxygen.
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 |
|---|---|---|---|---|
| May 1, 2012 | Z-1774-2012 | — | terminated | Capacitor failure may result in a fire hazard and loss of supplemental oxygen. |
| May 1, 2012 | Z-1779-2012 | — | terminated | Capacitor failure may result in a fire hazard and loss of supplemental oxygen. |
| May 1, 2012 | Z-1780-2012 | — | terminated | Capacitor failure may result in a fire hazard and loss of supplemental oxygen. |
| May 1, 2012 | Z-1781-2012 | — | terminated | Capacitor failure may result in a fire hazard and loss of supplemental oxygen. |
| May 1, 2012 | Z-1775-2012 | — | terminated | Capacitor failure may result in a fire hazard and loss of supplemental oxygen. |
| May 1, 2012 | Z-1777-2012 | — | terminated | Capacitor failure may result in a fire hazard and loss of supplemental oxygen. |
| May 1, 2012 | Z-1776-2012 | — | terminated | Capacitor failure may result in a fire hazard and loss of supplemental oxygen. |
| May 1, 2012 | Z-1778-2012 | — | terminated | Capacitor failure may result in a fire hazard and loss of supplemental oxygen. |
| May 1, 2012 | Z-1782-2012 | — | terminated | Capacitor failure may result in a fire hazard and loss of supplemental oxygen. |