510(k) Report

FDA applicant

Philips Respironics

Murrysville, PA2 decisions2011–20241 recall

FDA records 2 decisions for Philips Respironics (Murrysville, PA) from 2011 to 2024: 2 510(k) clearances. Most are in product codes BZD (Ventilator, Non-Continuous (Respirator)) and MNS (Ventilator, Continuous, Non-Life-Supporting). Its devices cite 2 predicates, 0 of them its own earlier devices. 1 recall is linked to its devices, 1 Class I.

FDA’s records also spell it “Philips Respironics, Inc.”.

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 Philips Respironics’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2011: 12024: 1
2011high 1 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

1in 2021

2021: 1, 1 Class I
2011high 1 (2021) · low 0 (2011)2026

Class I Class II/III not classified

FIG. 1 — Philips Respironics by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • BZDVentilator, Non-Continuous (Respirator)1decision
  • MNSVentilator, Continuous, Non-Life-Supporting1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K233555AF531 Oro-Nasal EE Leak 1 Face Mask; AF531 Oro-Nasal EE Leak 2 Face MaskPhilips Respironics · 2024
  • K111378Oximetry Interface KitPhilips Respironics, Inc. · 20111 Class I recall

The one decision as Philips Respironics →The one decision as Philips Respironics, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K092818DreamStation ASV, DreamStation ST, AVAPS, SystemOne ASV4, C-Series ASV, C-Series S/T and…Jun 14, 2021Class I