510(k) Report

FDA applicant

Respironics Inc., Sleep & Home Respiratory Group

Murrysville, PA21 decisions2007–201018 recalls

FDA records 21 decisions for Respironics Inc., Sleep & Home Respiratory Group (Murrysville, PA) from 2007 to 2010: 21 510(k) clearances. Most are in product codes BZD (Ventilator, Non-Continuous (Respirator)) and MNS (Ventilator, Continuous, Non-Life-Supporting). Its devices cite 42 predicates, 7 of them its own earlier devices. 18 recalls are linked to its devices, 13 Class I.

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 Respironics Inc., Sleep & Home Respiratory Group’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2007: 62008: 12009: 132010: 1
2007high 13 (2009) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

1in 2024

2007: 22010: 12011: 12012: 1, 1 Class I2014: 1, 1 Class I2016: 12021: 3, 3 Class I2022: 7, 7 Class I2024: 1, 1 Class I
2007high 7 (2022) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Respironics Inc., Sleep & Home Respiratory Group by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Respironics Inc., Sleep & Home…’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?

  • BZDVentilator, Non-Continuous (Respirator)10decisions
  • MNSVentilator, Continuous, Non-Life-Supporting4decisions
  • CBKVentilator, Continuous, Facility Use3decisions
  • MNRVentilatory Effort Recorder2decisions
  • CAWGenerator, Oxygen, Portable1decision
  • LBIUnit, Neonatal Phototherapy1decision

Whose devices does it build on?

Its devices cite 42 predicates; 7 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 48 times; 7 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.

  • K083526Trilogy 100 VentilatorRespironics Inc., Sleep & Home Respiratory Group · 20096cite it
  • K092835Comfortgel Nasal MaskRespironics Inc., Sleep & Home Respiratory Group · 20105cite it
  • K072592Performax Total Face MaskRespironics Inc., Sleep & Home Respiratory Group · 20074cite it
  • K073600Comfortgel Full Face MaskRespironics Inc., Sleep & Home Respiratory Group · 20084cite it
  • K070180Wallaby 4Respironics Inc., Sleep & Home Respiratory Group · 20074cite it
  • K090484Alice PDXRespironics Inc., Sleep & Home Respiratory Group · 20094cite it

What has FDA decided for it lately?

  • K092835Comfortgel Nasal MaskRespironics Inc., Sleep & Home Respiratory Group · 2010
  • K092648Respironics Performax SE Total Face MaskRespironics Inc., Sleep & Home Respiratory Group · 2009
  • K090539Bipap Autosv AdvancedRespironics Inc., Sleep & Home Respiratory Group · 20092 Class I recalls
  • K091191Gas TransfillRespironics Inc., Sleep & Home Respiratory Group · 2009
  • K091843Comfort Twin Nasal MaskRespironics Inc., Sleep & Home Respiratory Group · 2009
  • K091066Comfort Twin Nasal MaskRespironics Inc., Sleep & Home Respiratory Group · 2009
  • K091319Remstar Auto a-FlexRespironics Inc., Sleep & Home Respiratory Group · 20091 Class I recall
  • K090484Alice PDXRespironics Inc., Sleep & Home Respiratory Group · 2009

All 21 as Respironics Inc., Sleep & Home Respiratory Group →

What has been recalled?

18 recalls linked to its devices; the latest:

  • K121623OmniLab Advanced + Ventilator Product Numbers 1111122 1111123 1111124 1111125 1111126…Apr 1, 2024Class I
  • K083526Philips Garbin Ventilator, Model Number 1058180BDec 7, 2022Class I
  • K083526Philips Trilogy 100 Ventilator, Model Numbers 1054260, 1054096, U1054260, U1054260B…Dec 7, 2022Class I
  • K082866Philips Respironics Amara View Minimal Contact Full-Face MaskSep 6, 2022Class I
  • K090248Philips OmniLab Advanced + with Heated Tube Humidifier, Rx Only. To provide noninvasive…Aug 26, 2022Class I
  • K090248Philips OmniLab Advanced+, Rx Only. To provide noninvasive ventilation support for…Aug 26, 2022Class I

Other applicant names beginning “Respironics”

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

Respironics, Inc. 174Respironics California, Inc. 11Respironics Novametrix, Inc. 11Respironics New Jersey, Inc. 5Respironics Respiratory Drug Delivery (Uk), Ltd. 2Respironics Healthscan, Inc. 2Respironics Georgia, Inc. 2Respironics Inc. (Dba Philips Respironics) 1Respironics (Ireland) Limited 1