FDA applicant
Respcare, Inc.
FDA records 3 decisions for Respcare, Inc. (Coconut Creek, FL) from 2005 to 2006: 3 510(k) clearances. All are in product code BZD (Ventilator, Non-Continuous (Respirator)). Its devices cite 4 predicates, 1 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Respcare, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Respcare, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Respcare, 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