# Nidek Medical Products, Inc.

- Location (FDA's records): Birmingham, AL
- FDA decisions: 12 (1988–2020): 12 510(k) clearances
- Product codes: CAW (7), BZD (2), BYE (1), BTI (1), CCL (1)
- Predicates its devices cite: 8 (5 its own); citations of its devices by later devices: 6 (5 its own)
- Recalls linked to its devices: 7 (7 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Respironics, Inc.: 2 (https://510kreport.com/company/respironics)
- Puritan Bennett Corp.: 1 (https://510kreport.com/company/puritan-bennett)

## Firms that cite its devices most
- Zhongshan A&J Medical Equipment Co., Ltd.: 1 (https://510kreport.com/company/zhongshan-a-j-medical-equipment)

## Its most-cited devices
- K032509: Mark 5 Nuvo (M5C5) (2004), cited by 3
- K082566: Mark 5 Nuvo Lite Ocsi and STD (2008), cited by 1
- K040892: Mark 5 Nuvo Ocsi (M5C5), Models 505 and 905 (2004), cited by 1
- K883591: Mark-5 Concentrator (1988), cited by 1

## Recent decisions
- K192693: Nuvo Nano Portable Oxygen Concentrator (May 7, 2020)
- K123738: Mark 5 Nuvo Lite Ocsi, Mark 5 Nuvo Lite STD (Feb 28, 2013)
- K093308: Mark 5 Nuvo 8 Ocsi, Mark 5 Nuvo 8 STD (Jan 14, 2010)
- K082566: Mark 5 Nuvo Lite Ocsi and STD (Dec 3, 2008)
- K040892: Mark 5 Nuvo Ocsi (M5C5), Models 505 and 905 (Apr 29, 2004)
- K032509: Mark 5 Nuvo (M5C5) (Mar 18, 2004)
- K020797: Pulmo-Mist Compressor Model # 4323 (May 3, 2002)
- K980551: Silenzio Delta Continuous Positive Airway Pressure System (Nov 17, 1998)

Source page: https://510kreport.com/company/nidek-medical-products