FDA applicant
Gulf Coast Hyperbarics, Inc.
FDA records 3 decisions for Gulf Coast Hyperbarics, Inc. (Panama City, FL) from 1995 to 2009: 3 510(k) clearances. All are in product code CBF (Chamber, Hyperbaric). Its devices cite 3 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 Gulf Coast Hyperbarics, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2009
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Gulf Coast Hyperbarics, 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 “Gulf”
FDA records each applicant name separately; these may or may not be the same firm.