Mecron Medical Products, Inc.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Mecron Medical Products, Inc.” (first 1984, latest 1986), across 9 product codes in 4 review panels. Median 510(k) review time under this name: 92 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 |
|---|---|---|---|
| KWL | Prosthesis, Hip, Hemi-, Femoral, Metal | 3 | 3 |
| KTW | Appliance, Fixation, Nail/Blade/Plate Combination, Single Component | 2 | 2 |
| FCR | Light Source, Photographic, Fiberoptic | 1 | 1 |
| FFS | Image, Illumination, Fiberoptic, For Endoscope | 1 | 1 |
| GFD | Dermatome | 1 | 1 |
| HQO | Unit, Cautery, Thermal, Ac-Powered | 1 | 1 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 1 | 1 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Mecron Medical Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K861138 | MASH DERMATOME | GFD | 1986-04-14 | 19 |
| K854191 | MECRON UNCEMENTED STRUCTURED STEM HIP | — | 1985-11-13 | 93 |
| K844775 | EFFNER-EYE CAUTERY WITH BATTERY HANDLE | HQO | 1985-08-12 | 245 |
| K844774 | EFFNER FIBER OPTIC CABLES FOR COLD LIGHT TRANSMISS | FCR | 1985-04-22 | 133 |
| K844488 | MECRON CEMENTED STRUCTURED STEM HIP PROSTHESIS | KWL | 1985-03-12 | 113 |
| K844487 | MECRON FEMORAL HEAD W/CONE AS UNIPOLAR OR BIPOLAR | KWL | 1985-02-19 | 92 |
| K844486 | MECRON MRC-HEADLESS FEMORAL COMPONENT | KWL | 1985-02-19 | 92 |
| K844773 | EFF-EFFNER BULBS | FFS | 1985-01-08 | 29 |
| K843449 | AUTODYNAMIC COMPRESSION HIP SCREW-PLATE | KTT | 1984-10-22 | 47 |
| K843554 | BONE SCREWS | KTW | 1984-10-01 | 21 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Mecron Medical Products, 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 Mecron Medical Products, Inc.?
FDA lists 14 510(k) clearances under the applicant name “Mecron Medical Products, Inc.” (first 1984, latest 1986), across 9 product codes in 4 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 Mecron Medical Products, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Mecron Medical Products, Inc. is 92 days.
Which FDA product codes appear under Mecron Medical Products, Inc.?
The most frequent FDA product codes under this applicant name are KWL (Prosthesis, Hip, Hemi-, Femoral, Metal, 3); KTW (Appliance, Fixation, Nail/Blade/Plate Combination, Single Component, 2); FCR (Light Source, Photographic, Fiberoptic, 1).
Next steps
- See all 14 Mecron Medical Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KWL, Mecron Medical Products, 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.