Med-Tek Corp.: FDA clearances and approvals
Med-Tek Corp. has 16 FDA 510(k) clearances (first 1978, latest 1990), across 10 product codes in 4 review panels. Median 510(k) review time: 78 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 4 | 4 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 3 | 3 |
| LWJ | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | 2 | 2 |
| BTC | Bag, Reservoir | 1 | 1 |
| CAH | Filter, Bacterial, Breathing-Circuit | 1 | 1 |
| CAI | Circuit, Breathing (W Connector, Adaptor, Y Piece) | 1 | 1 |
| DXW | System, Phonocatheter, Intracavitary | 1 | 1 |
| HTY | Pin, Fixation, Smooth | 1 | 1 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 1 | 1 |
| KWA | Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) | 1 | 1 |
Review panels
- Orthopedic (9)
- Cardiovascular (4)
- Anesthesiology (2)
- General Hospital (1)
Most recent Med-Tek Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K903234 | F-19 TOTAL HIP PROSTHESIS | JDI | 1990-10-10 | 79 |
| K901687 | F-24 FEMORAL HIP PROSTHESIS | LWJ | 1990-09-07 | 148 |
| K901451 | F-20 CEMENTED METAL-BACKED ACETABULAR CUP | JDI | 1990-08-31 | 151 |
| K900428 | ANESTHESIA BREATHING CIRCUITS | CAI | 1990-08-17 | 199 |
| K901626 | H.N. METAL BACKED ACETABULAR CUP, NONCEMENTED | KWA | 1990-08-14 | 127 |
| K901594 | H.N. TOTAL HIP PROSTHESIS | LWJ | 1990-08-03 | 120 |
| K901480 | F-20 TOTAL HIP PROSTHESIS | JDI | 1990-06-12 | 77 |
| K901273 | L.M.S. SELF-DETACHABLE BROACH WITH STOP | HTY | 1990-06-05 | 78 |
| K901272 | ORION BLADE PLATE FOR TIBIAL OSTEOTOMY | KTT | 1990-04-23 | 35 |
| K901240 | ASTEL NON-METAL BACKED ACETABULAR CUP FOR CEMENTED | JDI | 1990-03-26 | 11 |
6 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Med-Tek Corp..
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 Med-Tek Corp. have?
Med-Tek Corp. has 16 FDA 510(k) clearances (first 1978, latest 1990), across 10 product codes in 4 review panels.
How long does FDA take to clear Med-Tek Corp.'s 510(k)s?
The median time from FDA receipt to decision across Med-Tek Corp.'s cleared 510(k)s is 78 days.
What devices does Med-Tek Corp. make?
Its most frequent FDA product codes are JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented, 4); DXN (System, Measurement, Blood-Pressure, Non-Invasive, 3); LWJ (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented, 2).
Has Med-Tek Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Med-Tek Corp. Related entities may recall under other names.
Next steps
- See all 16 Med-Tek Corp. clearances with predicates and recalls
- Run predicate analysis for product code JDI, Med-Tek 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.