510(k) Report

FDA applicant

Hpd Medical, Inc.

San Clemente, CA6 decisions1982–19930 recalls

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, last Nov 3, 2026

FIG. A — Illustration, anesthesiology panel, where it files most

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.

FIG. 1 — Hpd Medical, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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.

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