510(k) Report

FDA applicant

Hospital Concepts, Inc.

Burbank, CA2 decisions1986–19860 recalls

FDA records 2 decisions for Hospital Concepts, Inc. (Burbank, CA) in 1986: 2 510(k) clearances. Most are in product codes KOD (Catheter, Urological) and BSY (Catheters, Suction, Tracheobronchial). 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, gastroenterology and urology panel, where it files most

How often FDA has decided Hospital Concepts, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Hospital Concepts, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Hospital Concepts, 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

Other applicant names beginning “Hospital”

FDA records each applicant name separately; these may or may not be the same firm.