Chemence Medical, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Chemence Medical, Inc.” (first 2006, latest 2021), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 225 days. Since 2017 the median was 225 days, against 266 days for all cleared 510(k)s in the same product codes. 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 | 1 | 121 |
| 2017 | 1 | 132 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 2 | 343 |
| 2021 | 1 | 52 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Chemence Medical, Inc. took a median 225 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 266 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MPN | Tissue Adhesive For The Topical Approximation Of Skin | 3 | 3 |
| OMD | Cutaneous Tissue Adhesive With Mesh | 2 | 2 |
| KMF | Bandage, Liquid | 1 | 1 |
Review panels
Most recent Chemence Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K212246 | Exofin Precision Pen | MPN | 2021-09-09 | 52 |
| K200264 | Exofin High Viscosity Topical Skin Adhesive | MPN | 2020-12-17 | 318 |
| K191461 | Exofin Fusion Skin Closure System | OMD | 2020-06-05 | 368 |
| K171442 | Exofin Fusion Skin Closure System | OMD | 2017-09-25 | 132 |
| K162352 | derma+flex QS High Viscosity Tissue Adhesive | MPN | 2016-12-22 | 121 |
| K050757 | FLEX-AID LIQUID GEL BANDAGE AND DERMAFLEX GEL TISSUE ADHESIVE PROFESSIONAL LIQUID BANDAGE | KMF | 2006-02-23 | 337 |
Recalls
openFDA lists no recalls under a recalling firm named Chemence Medical, 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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Chemence Medical Products, Inc. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Chemence Medical, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Chemence Medical, Inc.” (first 2006, latest 2021), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Chemence Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Chemence Medical, Inc. is 225 days. Since 2017: 225 days, versus 266 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Chemence Medical, Inc.?
The most frequent FDA product codes under this applicant name are MPN (Tissue Adhesive For The Topical Approximation Of Skin, 3); OMD (Cutaneous Tissue Adhesive With Mesh, 2); KMF (Bandage, Liquid, 1).
Next steps
- See all 6 Chemence Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MPN, Chemence Medical, 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.