FDA applicant
Ad-Tech Medical Instrument Corp
FDA records 26 decisions for Ad-Tech Medical Instrument Corp (Racine, WI) from 1985 to 2023: 26 510(k) clearances. Most are in product codes GZL (Electrode, Depth) and GYC (Electrode, Cortical). Since 2016 its 510(k)s took a median of 170 days from receipt to decision, against 206 for FDA’s reviews in the same codes and years. Its devices cite 33 predicates, 20 of them its own earlier devices. 12 recalls are linked to its devices, 1 Class I.
FDA’s records also spell it “Ad-Tech Medical Instrument Corporation”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Ad-Tech Medical Instrument Corp’s devices, and how often a recall has named them.
FDA decisions per year
2in 2023
2026 so far, outlined.
Recalls per year
3in 2024
Class I Class II/III not classified
Planning a device like Ad-Tech Medical Instrument 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