FDA applicant
Coast Medical Corp.
FDA records 11 decisions for Coast Medical Corp. (Orange, CA) from 1992 to 1995: 11 510(k) clearances. Most are in product codes BTR (Tube, Tracheal (W/Wo Connector)) and FLL (Continuous Measurement Thermometer). 5 recalls are linked to its devices.
FDA’s records also spell it “Coast Medical, Inc.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Coast Medical Corp.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Coast Medical Corp. since 2007.
Recalls per year
2in 2015
Class I Class II/III not classified
Planning a device like Coast Medical Corp.’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 “Coast”
FDA records each applicant name separately; these may or may not be the same firm.