510(k) Report

FDA applicant

Nellcor Puritan Bennett, Inc.

Pleasanton, CA44 decisions1990–20077 recalls

FDA records 44 decisions for Nellcor Puritan Bennett, Inc. (Pleasanton, CA) from 1990 to 2007: 43 510(k) clearances and 1 original PMA approval. Most are in product codes DQA (Oximeter) and CBK (Ventilator, Continuous, Facility Use). Its devices cite 74 predicates, 23 of them its own earlier devices. 7 recalls are linked to its devices, 2 Class I.

FDA’s records also spell it “Nellcor Puritan Bennett”.

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

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

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

FDA decisions per year

2in 2007

2007: 2
2007high 2 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2024

2013: 1, 1 Class I2024: 1, 1 Class I
2007high 1 (2013) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Nellcor Puritan Bennett, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Nellcor Puritan Bennett, Inc.’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?

  • DQAOximeter19decisions
  • CBKVentilator, Continuous, Facility Use5decisions
  • BTMVentilator, Emergency, Manual (Resuscitator)3decisions
  • BZDVentilator, Non-Continuous (Respirator)3decisions
  • LRKDevice, Anti-Snoring2decisions
  • MNRVentilatory Effort Recorder2decisions

Also: DPS (2), DWJ (2), LSZ (1), CAF (1), BZG (1), NLF (1).

Whose devices does it build on?

Its devices cite 74 predicates; 23 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 148 times; 23 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.

  • K012891Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and Cables (Aka Accessories)Nellcor Puritan Bennett, Inc. · 200234cite it
  • K991823N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 199921cite it
  • K962516Tap Anti-Snoring DeviceNellcor Puritan Bennett, Inc. · 199613cite it
  • K993637N-395 Pulse Oximeter, with Extended Device ClaimsNellcor Puritan Bennett, Inc. · 199912cite it
  • K021090Oximax N-550 Pulse Oximeter,Model N-550 Pulse OximeterNellcor Puritan Bennett, Inc. · 200211cite it
  • K060576Nellcor Oximax N-600X Pulse OximeterNellcor Puritan Bennett, Inc. · 20067cite it

What has FDA decided for it lately?

  • K070899Puritan Bennett Legendair XL2Nellcor Puritan Bennett · 20071 Class I recall
  • K070408Duramax Reusable Oximetry SensorNellcor Puritan Bennett, Inc. · 2007
  • K060576Nellcor Oximax N-600X Pulse OximeterNellcor Puritan Bennett, Inc. · 2006
  • K051271Oximax Neomax Adhesive Forehead Reflectance Oximetry SensorNellcor Puritan Bennett, Inc. · 2006
  • K052186Nellcor Oximax Pulse Oximetry Sensons (Max-a, Max-AL, Max-N, Max-I, Max-PNellcor Puritan Bennett, Inc. · 2005
  • K051352Oximax NPB-40 Handheld Pulse OximeterNellcor Puritan Bennett, Inc. · 2005
  • K050072Goodknight 425STNellcor Puritan Bennett, Inc. · 2005
  • K033973Oxisensor II Recycled Sensor and Oximax Recycled SensorNellcor Puritan Bennett, Inc. · 2004

All 43 as Nellcor Puritan Bennett, Inc. →The one decision as Nellcor Puritan Bennett →

What has been recalled?

7 recalls linked to its devices; the latest:

  • K070899Puritan Bennett 500 Series Ventilators (Description/REF): PURITAN BENNETT 560…Jun 24, 2024Class I
  • K001646Puritan Bennett 840 ventilator systems software part number 4-070212-85, revision AB-AG.…Dec 16, 2013Class I
  • K030787Shiley FlexTra brand Flexible Dual-Cannula Tracheostomy Tube, Models: 358060, Size 6…Dec 9, 2004
  • K972837Nellcor brand Pulse Oximeter, Model NPB290, MALLINCKRODT, Made in Ireland, Oxismart…Oct 18, 2004
  • K973147Nellcor Puritan Bennett brand Pulse Oximeter, Model NPB295, Made in Ireland; Distributed…Oct 18, 2004
  • K012891Nellcor brand OxiMax Pulse Oximeter, model number N-595 Made in Ireland; Distributed by…Oct 18, 2004

Other applicant names beginning “Nellcor”

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

Nellcor, Inc. 18Nellcor Puritan Bennett France Dvpt. 2Nellcor Puritan Bennett (Melville), Ltd. 1