510(k) Report

FDA applicant

Respiratory Care, Inc.

Mchenry, IL26 decisions1976–198931 recalls

FDA records 26 decisions for Respiratory Care, Inc. (Mchenry, IL) from 1976 to 1989: 26 510(k) clearances. Most are in product codes BTT (Humidifier, Respiratory Gas, (Direct Patient…) and CAF (Nebulizer (Direct Patient Interface)). 31 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 Respiratory Care, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Respiratory Care, Inc. since 2007.

Recalls per year

15in 2015

2007: 12014: 152015: 15
2007high 15 (2014) · low 0 (2008)2026

Class I Class II/III not classified

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

Planning a device like Respiratory Care, 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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Other applicant names beginning “Respiratory”

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