Data / Medical devices / United States / Nihon Kohden Orangemed, LLC
Nihon Kohden Orangemed, LLC: FDA-registered device maker in Santa Ana, CA, United States, 5 510(k) clearances
Nihon Kohden Orangemed, LLC is registered with the FDA (registration 3014631252) in Santa Ana, CA, United States. It lists 3 device types. The FDA files 5 510(k) clearances under its listings, the newest dated March 1, 2024. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014631252
- Address
- 1800 E. Wilshire Avenue, Santa Ana, CA, United States, 92705
- Owner or operator
- Nihon Kohden OrangeMed, LLC (10059216)
- Roles
- Manufacturer, Specification developer
- First device listed
- December 12, 2018
- Registered through
- 2026
- Brand names listed
- Nihon Kohden Exhalation Port, Nihon Kohden NKV-330 Ventilator System, Nihon Kohden NKV-440 Ventilator System, Nihon Kohden NKV-550 Series Ventilator System, Nihon Kohden NPPV Cap-ONE Mask Set, O2 Manifold
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Continuous, Minimal Ventilatory Support, Facility Use Ventilator | MNT | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Tubing, Pressure And Accessories | BYX | 1 | Specification developer | accessdata.fda.gov |
| Ventilator, Continuous, Facility Use | CBK | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 1, 2024 | K231778 | Nihon Kohden NKV-550 Series Ventilator System | CBK | Substantially Equivalent | Nihon Kohden Orangemed, LLC | accessdata.fda.gov |
| May 31, 2023 | K222644 | Nihon Kohden NKV-440 Ventilator System | CBK | Substantially Equivalent | Nihon Kohden Orangemed, Inc. | accessdata.fda.gov |
| July 1, 2022 | K213521 | Nihon Kohden NKV-330 Ventilator System | MNT | Substantially Equivalent | Nihon Kohden Orangemed, Inc. | accessdata.fda.gov |
| January 10, 2020 | K192307 | Nihon Kohden NKV-550 Series Ventilator System | CBK | Substantially Equivalent | Nihon Kohden Orangemed, Inc. | accessdata.fda.gov |
| December 7, 2018 | K181695 | Nihon Kohden NKV-550 Series Ventilator System | CBK | Substantially Equivalent | Nihon Kohden Orangemed, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 20, 2021 | 88411 | Class II | Terminated | Nihon Kohden NKV-550 Ventilator, REF: NKV-550-U, CE 0344, UDI: (01) 00843685100012 The Nihon Kohden NKV-550 Series Ventilator System is intended to provide continuous ventilation for adult, pediatric and neonatal patient | Potential defective gas inlet pressure regulator within ventilator which could result in gas releasing noise from the bottom of the ventilator, a High Air/O2 Inlet Pressure alarm, a High/Low O2 alarm, or could not pass device Check prior to use. | accessdata.fda.gov |
Compare with other makers
- All makers of Ventilator, Continuous, Facility Use
- All makers of Tubing, Pressure And Accessories
- All makers of Continuous, Minimal Ventilatory Support, Facility Use Ventilator
Updated March 1, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.