510(k) Report

FDA applicant

Controlled Therapeutics Corp.

Malvern, PA4 decisions1989–19890 recalls

FDA records 4 decisions for Controlled Therapeutics Corp. (Malvern, PA) in 1989: 4 510(k) clearances. Most are in product codes KOZ (Beads, Hydrophilic, For Wound Exudate Absorption) and KGX (Tape And Bandage, Adhesive). 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, general hospital panel, where it files most

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

FDA decisions per year

No FDA decision for Controlled Therapeutics Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Controlled Therapeutics Corp.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Controlled”

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