FDA applicant
Respironics, Inc.
FDA records 174 decisions for Respironics, Inc. (Murrysville, PA) from 1977 to 2026: 174 510(k) clearances. Most are in product codes BZD (Ventilator, Non-Continuous (Respirator)) and CBK (Ventilator, Continuous, Facility Use). Since 2016 its 510(k)s took a median of 159 days from receipt to decision, against 216 for FDA’s reviews in the same codes and years. Its devices cite 215 predicates, 116 of them its own earlier devices. 129 recalls are linked to its devices, 72 Class I.
FDA’s records also spell it “Respironics , Ltd.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Respironics, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
6in 2026
Class I Class II/III not classified
Planning a device like Respironics, 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) ReportOther applicant names beginning “Respironics”
FDA records each applicant name separately; these may or may not be the same firm.