Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ad-Tech Medical Instrument Corp — Predicate Candidate Screening
18 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
174 daysmedian FDA review time
277 days90th percentile
18clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K112094 | BRAIN BIOPSY NEEDLE | Ad-Tech Medical Instrument Corp | 2012-04-24 | 277 | 0 |
| K053363 | DUAL-SIDED INTERHEMISPHERIC SUBDURAL ELECTRODES, GRID SUBDUR | Ad-Tech Medical Instrument Corp | 2006-05-30 | 179 | 1 |
| K053358 | DEPTH ELECTRODE, FORAMEN OVALE DEPTH ELECTRODES, WYLER SPHEN | Ad-Tech Medical Instrument Corp | 2006-05-25 | 174 | 0 |
| K041604 | MACRO-MICRO DEPTH ELECTRODE | Ad-Tech Medical Instrument Corp | 2004-08-16 | 63 | 0 |
| K990788 | AD-TECH'S FORAMEN OVALE ELECTRODE | Ad-Tech Medical Instrument Corp | 1999-11-02 | 237 | 0 |
| K992194 | CORTICAL MAPPING UNIT, MODEL CMU | Ad-Tech Medical Instrument Corp | 1999-09-13 | 76 | 0 |
| K973454 | AD-TECH'S SPINAL ELECTRODE | Ad-Tech Medical Instrument Corp | 1998-06-10 | 272 | 0 |
| K964644 | AD-TECH'S DEPTH ELECTRODE | Ad-Tech Medical Instrument Corp | 1997-05-09 | 190 | 0 |
| K970587 | AD-TECH SUBDURAL ELECTRODE | Ad-Tech Medical Instrument Corp | 1997-05-09 | 80 | 0 |
| K940320 | AD-TECH'S RAAB INFANT NASOPHARYNGEAL PRONGS | Ad-Tech Medical Instrument Corp | 1995-09-19 | 603 | 0 |
| K944061 | CUEVA CRANIAL NERVE ELECTRODE | Ad-Tech Medical Instrument Corp | 1995-01-20 | 154 | 1 |
| K924348 | AD-TECH'S BRAIN BIOPSY NEEDLE FOR STEREOTAXIC | Ad-Tech Medical Instrument Corp | 1992-11-23 | 88 | 0 |
| K923803 | AD-TECH SUB DURAL ELECTRODEDS | Ad-Tech Medical Instrument Corp | 1992-10-23 | 86 | 0 |
| K912760 | AD-TECH EPIDURAL PEG ELECTRODE | Ad-Tech Medical Instrument Corp | 1992-01-15 | 205 | 0 |
| K891920 | AD-TECH'S DEPTH ELECTRODE | Ad-Tech Medical Instrument Corp | 1989-07-27 | 122 | 0 |
| K864194 | PALMER OBSTETRIC BRACE | Ad-Tech Medical Instrument Corp | 1987-01-14 | 79 | 0 |
| K861031 | WYLER SPHENOIDAL ELECTRODE | Ad-Tech Medical Instrument Corp | 1986-08-25 | 160 | 0 |
| K850342 | WYLER SUBDURAL STRIP ELECTRODE | Ad-Tech Medical Instrument Corp | 1985-07-30 | 183 | 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