Med-Tool, Inc.: FDA filings under this applicant name
FDA lists 28 510(k) clearances under the applicant name “Med-Tool, Inc.” (first 1984, latest 1987), across 9 product codes in 2 review panels. Median 510(k) review time under this name: 26 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 |
|---|---|---|---|
| HTC | Pliers, Surgical | 9 | 9 |
| LRY | Punch, Surgical | 3 | 3 |
| HXC | Wrench | 2 | 2 |
| GEO | File, Surgical, General & Plastic Surgery | 1 | 1 |
| HXD | Clamp | 1 | 1 |
| HXX | Screwdriver | 1 | 1 |
| LRZ | Screwdriver, Surgical | 1 | 1 |
| LSA | Vise, Bench, Surgical | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Med-Tool, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K874359 | ADJUSTABLE WRENCHES | HXC | 1987-11-23 | 31 |
| K874358 | COMBINATION WRENCHES | HXC | 1987-11-23 | 31 |
| K874357 | TAPERED PUNCH | LRY | 1987-11-23 | 31 |
| K874356 | PIN PUNCH | LRY | 1987-11-23 | 31 |
| K872388 | NAIL SET | LRY | 1987-07-23 | 34 |
| K872387 | STANDARD SCREW DRIVER | LRZ | 1987-07-16 | 27 |
| K872385 | VICE OR BENCH VICE | LSA | 1987-07-16 | 27 |
| K872389 | PRECISION SCREW DRIVER SET | HXX | 1987-07-15 | 26 |
| K872386 | C CLAMP | HXD | 1987-07-02 | 13 |
| K872384 | SIDE CUTTING PARALLEL ACTION PLIERS | HTC | 1987-07-02 | 13 |
18 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Med-Tool, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Med-Tool, Inc.?
FDA lists 28 510(k) clearances under the applicant name “Med-Tool, Inc.” (first 1984, latest 1987), across 9 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Med-Tool, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Med-Tool, Inc. is 26 days.
Which FDA product codes appear under Med-Tool, Inc.?
The most frequent FDA product codes under this applicant name are HTC (Pliers, Surgical, 9); LRY (Punch, Surgical, 3); HXC (Wrench, 2).
Next steps
- See all 28 Med-Tool, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HTC, Med-Tool, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.