510(k) Report

FDA applicant

Wicab, Inc.

Philedelphia, PA2 decisions2015–20150 recalls

FDA records 2 decisions for Wicab, Inc. (Philedelphia, PA) in 2015: 1 510(k) clearance and 1 De Novo grant. All are in product code PIC (Oral Electronic Vision Aid). Its devices cite 1 predicate, 1 of them its own earlier devices. 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 Wicab, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2015

2015: 2
2015high 2 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Wicab, Inc. by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Wicab, 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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