Ad-Tech Medical Instrument Corp: FDA clearances and approvals
Ad-Tech Medical Instrument Corp has 26 FDA 510(k) clearances (first 1985, latest 2023), across 7 product codes in 4 review panels. Median 510(k) review time: 178 days. Since 2017 its median was 206 days, against 145 days for all cleared 510(k)s in the same product codes. openFDA lists 17 product recalls by a recalling firm named Ad-Tech Medical Instrument Corp.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 277 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 2 | 201 |
| 2017 | 2 | 169 |
| 2018 | 1 | 58 |
| 2019 | 0 | — |
| 2020 | 1 | 267 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 2 | 206 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Ad-Tech Medical Instrument Corp's cleared 510(k)s took a median 206 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 145 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GZL | Electrode, Depth | 13 | 13 |
| GYC | Electrode, Cortical | 7 | 7 |
| HAW | Neurological Stereotaxic Instrument | 2 | 2 |
| BTQ | Airway, Nasopharyngeal | 1 | 1 |
| ETN | Stimulator, Nerve | 1 | 1 |
| HBE | Drills, Burrs, Trephines & Accessories (Simple, Powered) | 1 | 1 |
| KNC | Table, Obstetric (And Accessories) | 1 | 1 |
Review panels
- Neurology (23)
- Anesthesiology (1)
- Ear, Nose and Throat (1)
- Obstetrics and Gynecology (1)
Most recent Ad-Tech Medical Instrument Corp 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K223276 | Anchor Bolts as Accessories to Depth Electrodes | GZL | 2023-05-18 | 206 |
| K223269 | Spencer Probe Depth Electrodes | GZL | 2023-05-18 | 206 |
| K191186 | Subdural Strip/Intraoperative Split Electrode, Subdural Grid/Intraoperative Grid Electrode, Dual-Sided Interhemispheric Subdural Electrode, Multi-Strip and Slit Grid Subdural Electrode, Intraoperative Mapping Grid Subdural Electrode | GYC | 2020-01-25 | 267 |
| K181544 | Anchor Bolt (as an accessory to Depth Electrodes) | GZL | 2018-08-09 | 58 |
| K170442 | Cranial Drill Bits and Accessories | HBE | 2017-09-07 | 205 |
| K163355 | Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes | GZL | 2017-04-12 | 133 |
| K152769 | FREMAP ELECTRODE | ETN | 2016-05-06 | 224 |
| K152547 | DNAP Electrode | GZL | 2016-03-04 | 178 |
| K112094 | BRAIN BIOPSY NEEDLE | HAW | 2012-04-24 | 277 |
| K053363 | DUAL-SIDED INTERHEMISPHERIC SUBDURAL ELECTRODES, GRID SUBDURAL ELECTRODES, INTRAOPERATIVE SUBDURAL ELECTRODES | GYC | 2006-05-30 | 179 |
16 earlier clearances. See the full list in Caduvo.
Recalls
17 product recalls in 11 recall events; 3 initiated in the last five years. Most recent: 2024-09-19.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Ad-Tech Medical Instrument Corp have?
Ad-Tech Medical Instrument Corp has 26 FDA 510(k) clearances (first 1985, latest 2023), across 7 product codes in 4 review panels.
How long does FDA take to clear Ad-Tech Medical Instrument Corp's 510(k)s?
The median time from FDA receipt to decision across Ad-Tech Medical Instrument Corp's cleared 510(k)s is 178 days. Since 2017: 206 days, versus 145 days for all cleared 510(k)s in the same product codes.
What devices does Ad-Tech Medical Instrument Corp make?
Its most frequent FDA product codes are GZL (Electrode, Depth, 13); GYC (Electrode, Cortical, 7); HAW (Neurological Stereotaxic Instrument, 2).
Has Ad-Tech Medical Instrument Corp had device recalls?
openFDA lists 17 product recalls in 11 recall events by a recalling firm whose name matches Ad-Tech Medical Instrument Corp; the most recent began 2024-09-19. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 26 Ad-Tech Medical Instrument Corp clearances with predicates and recalls
- Run predicate analysis for product code GZL, Ad-Tech Medical Instrument Corp's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.