# Covidien, Formerly Nellcor Puritan Bennett, Inc.

- Location (FDA's records): Boulder, CO
- FDA decisions: 5 (2008–2013): 5 510(k) clearances
- Product codes: CBK (3), MWI (1), DQA (1)
- Predicates its devices cite: 8 (0 its own); citations of its devices by later devices: 7 (0 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Puritan Bennett Corp.: 2 (https://510kreport.com/company/puritan-bennett)
- Nellcor Puritan Bennett, Inc.: 2 (https://510kreport.com/company/nellcor-puritan-bennett)
- Cardinal Health 207, Inc.: 1 (https://510kreport.com/company/cardinal-health-207)
- Geratherm Medical AG: 1 (https://510kreport.com/company/geratherm-medical)
- Maquet Critical Care AB: 1 (https://510kreport.com/company/maquet-critical-care)
- Hamilton Medical AG: 1 (https://510kreport.com/company/hamilton-medical)

## Firms that cite its devices most
- Covidien: 5 (https://510kreport.com/company/covidien)
- Care Fusion: 1 (https://510kreport.com/company/care-fusion)
- Etiometry, Inc.: 1 (https://510kreport.com/company/etiometry)

## Its most-cited devices
- K123581: Nellcor Oximax N-600X Pulse Oximeter, Nellcor Bedside Respiratory Patient Monitoring System, Nellcor Bedside SPO2 Patien (2013), cited by 3
- K092847: 840 Ventilator System with Expanded Neomode Option (2010), cited by 2
- K123002: Vital Sync System (2013), cited by 1
- K083693: PB 840 Ventilator System  with Leak Compensation Option, Model 840 (2009), cited by 1

## Recent decisions
- K123581: Nellcor Oximax N-600X Pulse Oximeter, Nellcor Bedside Respiratory Patient Monitoring System, Nellcor Bedside SPO2 Patien (May 9, 2013)
- K123002: Vital Sync System (Feb 27, 2013)
- K092847: 840 Ventilator System with Expanded Neomode Option (Mar 11, 2010)
- K083693: PB 840 Ventilator System  with Leak Compensation Option, Model 840 (Apr 2, 2009)
- K082966: PB 540 Ventilator (Oct 31, 2008)

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