510(k) Report

FDA applicant

Bio Clinic Co.

St. Louis, MI14 decisions1988–19930 recalls

FDA records 14 decisions for Bio Clinic Co. (St. Louis, MI) from 1988 to 1993: 14 510(k) clearances. Most are in product codes IOQ (Bed, Flotation Therapy, Powered) and JHI (Visual, Pregnancy Hcg, Prescription Use). 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, clinical chemistry panel, where it files most

How often FDA has decided Bio Clinic Co.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Bio Clinic Co. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Bio Clinic Co.’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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