510(k) Report

FDA applicant

Transdermal Cap, Inc.

Cleveland, OH3 decisions2015–20210 recalls

FDA records 3 decisions for Transdermal Cap, Inc. (Cleveland, OH) from 2015 to 2021: 3 510(k) clearances. All are in product code OAP (Laser, Comb, Hair). Its devices cite 9 predicates, 3 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, physical medicine panel, where it files most

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

FDA decisions per year

1in 2021

2015: 12016: 12021: 1
2015high 1 (2015) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

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

Planning a device like Transdermal Cap, 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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