Kerma Medical Products, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Kerma Medical Products, Inc.” (first 1991, latest 1994), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 87 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 |
|---|---|---|---|
| NAB | Gauze / Sponge,Nonresorbable For External Use | 4 | 4 |
| LYU | Accessory, Surgical Apparel | 1 | 1 |
Review panels
Most recent Kerma Medical Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K931042 | MOORE SECURE CAP | LYU | 1994-04-13 | 408 |
| K915821 | MULTIPLE STERILE GAUZE BANDAGE ROLLS, VARI SIZES | NAB | 1992-05-29 | 151 |
| K915822 | MULTIPLE DRESSING, STERILE NONADDHERENT PADS | NAB | 1992-03-26 | 87 |
| K914937 | STERILE BANDAGE, GAUZE, FINE MESH, 3X8 INCHES | NAB | 1991-12-04 | 30 |
| K914071 | MULTIPLE BURN DRESSING | NAB | 1991-12-04 | 84 |
Recalls
openFDA lists no recalls under a recalling firm named Kerma 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 Kerma Medical Products, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Kerma Medical Products, Inc.” (first 1991, latest 1994), across 2 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 Kerma Medical Products, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Kerma Medical Products, Inc. is 87 days.
Which FDA product codes appear under Kerma Medical Products, Inc.?
The most frequent FDA product codes under this applicant name are NAB (Gauze / Sponge,Nonresorbable For External Use, 4); LYU (Accessory, Surgical Apparel, 1).
Next steps
- See all 5 Kerma Medical Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code NAB, Kerma 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.