# Nihon Kohden Orangemed, Inc.

- Location (FDA's records): Santa Ana, CA
- FDA decisions: 5 (2018–2024): 5 510(k) clearances
- Names in FDA's records: Nihon Kohden Orangemed, Inc. (4); Nihon Kohden Orangemed, LLC (1)
- Product codes: CBK (4), MNT (1)
- 510(k) review time since 2016: median 211 days, against 193 for FDA's reviews in the same codes and years (3 of 4 faster)
- Predicates its devices cite: 6 (3 its own); citations of its devices by later devices: 6 (3 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Hamilton Medical AG: 1 (https://510kreport.com/company/hamilton-medical)
- Draegerwerk AG & CO Kgaa: 1 (https://510kreport.com/company/draegerwerk-ag-co-kgaa)
- Respironics, Inc.: 1 (https://510kreport.com/company/respironics)

## Firms that cite its devices most
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-mindray-bio-medical-electronics)
- Mekics Co., Ltd.: 1 (https://510kreport.com/company/mekics)
- Innaccel Technologies Private Limited: 1 (https://510kreport.com/company/innaccel-technologies-private)

## Its most-cited devices
- K192307: Nihon Kohden NKV-550 Series Ventilator System (2020), cited by 2
- K213521: Nihon Kohden NKV-330 Ventilator System (2022), cited by 2
- K222644: Nihon Kohden NKV-440 Ventilator System (2023), cited by 1
- K181695: Nihon Kohden NKV-550 Series Ventilator System (2018), cited by 1

## Recent decisions
- K231778: Nihon Kohden NKV-550 Series Ventilator System (Mar 1, 2024)
- K222644: Nihon Kohden NKV-440 Ventilator System (May 31, 2023)
- K213521: Nihon Kohden NKV-330 Ventilator System (Jul 1, 2022)
- K192307: Nihon Kohden NKV-550 Series Ventilator System (Jan 10, 2020)
- K181695: Nihon Kohden NKV-550 Series Ventilator System (Dec 7, 2018)

Source page: https://510kreport.com/company/nihon-kohden-orangemed