510(k) Report

FDA applicant

Infab Corp.

Camarillo, CA6 decisions1989–19900 recalls

FDA records 6 decisions for Infab Corp. (Camarillo, CA) from 1989 to 1990: 6 510(k) clearances. Most are in product codes KPY (Shield, Protective, Personnel) and IWP (Radiographic Protective Glove). 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, radiology panel, where it files most

How often FDA has decided Infab Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Infab Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Infab Corp.’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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