FDA applicant

Berkeley Bio-Engineering

Mchenry, IL4 decisions1977–19790 recalls

FDA records 4 decisions for Berkeley Bio-Engineering (Mchenry, IL) from 1977 to 1979: 4 510(k) clearances. Most are in product codes HQE (Instrument, Vitreous Aspiration And Cutting…) and HSZ (Instrument, Surgical, Orthopedic, Pneumatic…). 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, ophthalmic panel, where it files most

How often FDA has decided Berkeley Bio-Engineering’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Berkeley Bio-Engineering since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Berkeley Bio-Engineering’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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Other applicant names beginning “Berkeley”

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

Berkeley Advanced Biomaterials, Inc. 16 Berkeley Electric Wheelchair Co. 6 Berkeley Medevices 5 Berkeley Bio-Medical, Inc. 2

Berkeley Bio-Engineering

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Berkeley”