510(k) Report

FDA applicant

Covidien, Formerly Nellcor Puritan Bennett, Inc.

Boulder, CO5 decisions2008–20132 recalls

FDA records 5 decisions for Covidien, Formerly Nellcor Puritan Bennett, Inc. (Boulder, CO) from 2008 to 2013: 5 510(k) clearances. Most are in product codes CBK (Ventilator, Continuous, Facility Use) and MWI (Monitor, Physiological, Patient (Without…). Its devices cite 8 predicates, 0 of them its own earlier devices. 2 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, anesthesiology panel, where it files most

How often FDA has decided Covidien, Formerly Nellcor Puritan Bennett, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2013

2008: 12009: 12010: 12013: 2
2008high 2 (2013) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

2in 2015

2015: 2
2008high 2 (2015) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Covidien, Formerly Nellcor Puritan Bennett, Inc. by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Covidien, Formerly Nellcor Puritan…’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • CBKVentilator, Continuous, Facility Use3decisions
  • MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)1decision
  • DQAOximeter1decision

Whose devices does it build on?

Its devices cite 8 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K123581Nellcor Oximax N-600X Pulse Oximeter, Nellcor Bedside Respiratory Patient Monitoring System, Nellcor Bedside…Covidien, Formerly Nellcor Puritan Bennett, Inc. · 20133cite it
  • K092847840 Ventilator System with Expanded Neomode OptionCovidien, Formerly Nellcor Puritan Bennett, Inc. · 20102cite it
  • K123002Vital Sync SystemCovidien, Formerly Nellcor Puritan Bennett, Inc. · 20131cites it
  • K083693PB 840 Ventilator System with Leak Compensation Option, Model 840Covidien, Formerly Nellcor Puritan Bennett, Inc. · 20091cites it

What has FDA decided for it lately?

  • K123581Nellcor Oximax N-600X Pulse Oximeter, Nellcor Bedside Respiratory Patient Monitoring System, Nellcor Bedside…Covidien, Formerly Nellcor Puritan Bennett, Inc. · 20132 recalls
  • K123002Vital Sync SystemCovidien, Formerly Nellcor Puritan Bennett, Inc. · 2013
  • K092847840 Ventilator System with Expanded Neomode OptionCovidien, Formerly Nellcor Puritan Bennett, Inc. · 2010
  • K083693PB 840 Ventilator System with Leak Compensation Option, Model 840Covidien, Formerly Nellcor Puritan Bennett, Inc. · 2009
  • K082966PB 540 VentilatorCovidien, Formerly Nellcor Puritan Bennett, Inc. · 2008

All 5 as Covidien, Formerly Nellcor Puritan Bennett, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K123581OxiMax N-65 Handheld Pulse Oximeter. N65, N65-1, N65P, and N65P-1. For continuous or…Jun 29, 2015Class II
  • K123581OxiMax N-560 Pulse Oximeter. For continuous or spot check monitoring of functional…Jun 29, 2015Class II

Other applicant names beginning “Covidien”

FDA records each applicant name separately; these may or may not be the same firm.

Covidien 227Covidien, Formerly US Surgical A Divison of Tyco H 13Covidien Lp, Formerly Registered AS United States 8Covidien, Formerly Valleylab, A Division of Tyco H 6Covidien Lp, Formerly Registered AS Tyco Healthcar 4Covidien Lp, Formerly Registered AS Kendall 3Covidien, LLC ( Formerly Beacon Endoscopic Corp.) 2Covidien (Part of Medtronic) 2Covidien, LLC, Formerly Registered AS Tyco Healthca 2Covidien Lp, Formerly Know AS Valleylab, A Divison 2Covidien (Dba Medtronic) 1Covidien UK Manufacturing, Ltd. 1