FDA applicant
Respironics California, Inc.
FDA records 11 decisions for Respironics California, Inc. (Carlsbad, CA) from 2002 to 2012: 11 510(k) clearances. Most are in product codes CBK (Ventilator, Continuous, Facility Use) and NOU (Continuous, Ventilator, Home Use). Its devices cite 34 predicates, 4 of them its own earlier devices. 54 recalls are linked to its devices, 4 Class I.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Respironics California, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2012
2026 so far, outlined.
Recalls per year
1in 2021
Class I Class II/III not classified
Planning a device like Respironics California, 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.