510(k) Report

FDA applicant

Respironics (Ireland) Limited

Galway, IE1 decision2006–20061 recall

FDA records 1 decision for Respironics (Ireland) Limited (Galway, IE) in 2006: 1 510(k) clearance. All are in product code MNS (Ventilator, Continuous, Non-Life-Supporting). Its devices cite 3 predicates, 0 of them its own earlier devices. 1 recall is 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 Respironics (Ireland) Limited’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Respironics (Ireland) Limited since 2007.

Recalls per year

1in 2008

2008: 1
2007high 1 (2008) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Respironics (Ireland) Limited by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MNSVentilator, Continuous, Non-Life-Supporting1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K053168Bipap FocusRespironics (Ireland) Limited · 20061cites it

What has FDA decided for it lately?

  • K053168Bipap FocusRespironics (Ireland) Limited · 20061 recall

The one decision as Respironics (Ireland) Limited →

What has been recalled?

1 recall linked to its devices; the latest:

  • K053168Respironics BiPAP Focus Noninvasive Ventilator System. The BiPAP Focus is a…Sep 22, 2008

Other applicant names beginning “Respironics”

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

Respironics, Inc. 174Respironics Inc., Sleep & Home Respiratory Group 21Respironics 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) 1