FDA applicant

International Respiratory Systems, Inc.

Crofton, MD3 decisions1992–19983 recalls

FDA records 3 decisions for International Respiratory Systems, Inc. (Crofton, MD) from 1992 to 1998: 3 510(k) clearances. Most are in product codes BTM (Ventilator, Emergency, Manual (Resuscitator)) and BYE (Attachment, Breathing, Positive End Expiratory…). 3 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 International Respiratory Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for International Respiratory Systems, Inc. since 2007.

Recalls per year

3in 2019

2007high 3 (2019) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like International Respiratory Systems, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

International Respiratory Systems, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

What has been recalled?