FDA applicant
Hpd Medical, Inc.
FDA records 6 decisions for Hpd Medical, Inc. (San Clemente, CA) from 1982 to 1993: 6 510(k) clearances. Most are in product codes BTT (Humidifier, Respiratory Gas, (Direct Patient…) and BZE (Heater, Breathing System W/Wo Controller (Not…). 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 Hpd Medical, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Hpd Medical, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Hpd Medical, 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