# Nellcor Puritan Bennett, Inc.

- Location (FDA's records): Pleasanton, CA
- FDA decisions: 44 (1990–2007): 43 510(k) clearances and 1 original PMA approval
- Names in FDA's records: Nellcor Puritan Bennett, Inc. (43); Nellcor Puritan Bennett (1)
- Product codes: DQA (19), CBK (5), BTM (3), BZD (3), LRK (2), MNR (2), DPS (2), DWJ (2), LSZ (1), CAF (1), BZG (1), NLF (1)
- Predicates its devices cite: 74 (23 its own); citations of its devices by later devices: 148 (23 its own)
- Recalls linked to its devices: 7 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Nellcor, Inc.: 11 (https://510kreport.com/company/nellcor)
- Ohmeda Medical: 5 (https://510kreport.com/company/ohmeda-medical)
- Puritan Bennett Corp.: 3 (https://510kreport.com/company/puritan-bennett)
- Shiley, Inc.: 3 (https://510kreport.com/company/shiley)
- Ivy Biomedical Systems, Inc.: 2 (https://510kreport.com/company/ivy-biomedical-systems)
- Bird Products Corp.: 2 (https://510kreport.com/company/bird-products)
- Dr. Thomas E. Meade: 2 (https://510kreport.com/company/dr-thomas-e-meade)
- Melville Software, Ltd.: 2 (https://510kreport.com/company/melville-software)

## Firms that cite its devices most
- Cas Medical Systems, Inc.: 7 (https://510kreport.com/company/cas-medical-systems)
- Covidien: 6 (https://510kreport.com/company/covidien)
- Ge Medical Systems Information Technologies: 6 (https://510kreport.com/company/ge-medical-systems-information-technologies)
- Masimo Corporation: 5 (https://510kreport.com/company/masimo)
- Welch Allyn Protocol, Inc.: 4 (https://510kreport.com/company/welch-allyn-protocol)
- American I.V. Products, Inc.: 4 (https://510kreport.com/company/american-iv-products)
- Sentec AG: 3 (https://510kreport.com/company/sentec)
- Elekon Industries U.S.A., Inc.: 3 (https://510kreport.com/company/elekon-industries-usa)

## Its most-cited devices
- K012891: Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and Cables (Aka Accessories) (2002), cited by 34
- K991823: N-395 Pulse Oximeter, Model N-395 (1999), cited by 21
- K962516: Tap Anti-Snoring Device (1996), cited by 13
- K993637: N-395 Pulse Oximeter, with Extended Device Claims (1999), cited by 12
- K021090: Oximax N-550 Pulse Oximeter,Model N-550 Pulse Oximeter (2002), cited by 11
- K060576: Nellcor Oximax N-600X Pulse Oximeter (2006), cited by 7

## Recent decisions
- K070899: Puritan Bennett Legendair XL2 (Dec 13, 2007)
- K070408: Duramax Reusable Oximetry Sensor (May 25, 2007)
- K060576: Nellcor Oximax N-600X Pulse Oximeter (Aug 14, 2006)
- K051271: Oximax Neomax Adhesive Forehead Reflectance Oximetry Sensor (Jan 10, 2006)
- K052186: Nellcor Oximax Pulse Oximetry Sensons (Max-a, Max-AL, Max-N, Max-I, Max-P (Nov 10, 2005)
- K051352: Oximax NPB-40 Handheld Pulse Oximeter (Aug 11, 2005)
- K050072: Goodknight 425ST (Jun 13, 2005)
- K033973: Oxisensor II Recycled Sensor and Oximax Recycled Sensor (Dec 13, 2004)

Source page: https://510kreport.com/company/nellcor-puritan-bennett