Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Ad-Tech Medical Instrument Corporation · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
206 daysmedian FDA review time
267 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K223269 | Spencer Probe Depth Electrodes | Ad-Tech Medical Instrument Corporation | 2023-05-18 | 206 | 0 |
| K223276 | Anchor Bolts as Accessories to Depth Electrodes | Ad-Tech Medical Instrument Corporation | 2023-05-18 | 206 | 0 |
| K191186 | Subdural Strip/Intraoperative Split Electrode, Subdural Grid | Ad-Tech Medical Instrument Corporation | 2020-01-25 | 267 | 0 |
| K181544 | Anchor Bolt (as an accessory to Depth Electrodes) | Ad-Tech Medical Instrument Corporation | 2018-08-09 | 58 | 0 |
| K170442 | Cranial Drill Bits and Accessories | Ad-Tech Medical Instrument Corporation | 2017-09-07 | 205 | 0 |
| K163355 | Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro | Ad-Tech Medical Instrument Corporation | 2017-04-12 | 133 | 3 |
| K152769 | FREMAP ELECTRODE | Ad-Tech Medical Instrument Corporation | 2016-05-06 | 224 | 0 |
| K152547 | DNAP Electrode | Ad-Tech Medical Instrument Corporation | 2016-03-04 | 178 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda