Brennen Medical, Inc.: FDA clearances and approvals
Brennen Medical, Inc. has 20 FDA 510(k) clearances (first 1994, latest 2012), across 8 product codes in 2 review panels. Median 510(k) review time: 84 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 84 |
| 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 |
|---|---|---|---|
| MGQ | Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic | 7 | 7 |
| KGN | Wound Dressing With Animal-Derived Material(S) | 4 | 4 |
| FTM | Mesh, Surgical | 2 | 2 |
| MDA | Elastomer, Silicone, For Scar Management | 2 | 2 |
| PAG | Mesh, Surgical, Non-Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator | 2 | 2 |
| FRO | Dressing, Wound, Drug | 1 | 1 |
| FTL | Mesh, Surgical, Polymeric | 1 | 1 |
| KMF | Bandage, Liquid | 1 | 1 |
Review panels
Most recent Brennen Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K113866 | PORCINE DERMAL XENOGRAFTS PORCINE DERMAL MATRIX | KGN | 2012-03-23 | 84 |
| K111436 | PORCINE SURGICAL MESH, PORCINE DERMAL MATRIX | FTM | 2011-10-14 | 143 |
| K081272 | PORCINE SURGICAL MESH; DERMAL MATRIX | FTM | 2008-07-31 | 87 |
| K050086 | BRENNEN MEDICAL SILVER GLUCAN WOUND DRESSING | FRO | 2006-02-17 | 400 |
| K030460 | MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX | PAG | 2003-03-07 | 23 |
| K021835 | BRENNEN MEDICAL SURGICAL MESH, GLUCAMESH/GLUCATEX | FTL | 2002-10-17 | 135 |
| K002078 | BETA GLUCAN GEL (MACROPRO GEL) | MGQ | 2000-10-02 | 84 |
| K002077 | GLUCANPRO CREAM | MGQ | 2000-10-02 | 84 |
| K000519 | GLUCANPRO | MGQ | 2000-05-01 | 75 |
| K000518 | MACROPRO GEL | MGQ | 2000-05-01 | 75 |
10 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Brennen Medical, Inc..
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 Brennen Medical, Inc. have?
Brennen Medical, Inc. has 20 FDA 510(k) clearances (first 1994, latest 2012), across 8 product codes in 2 review panels.
How long does FDA take to clear Brennen Medical, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Brennen Medical, Inc.'s cleared 510(k)s is 84 days.
What devices does Brennen Medical, Inc. make?
Its most frequent FDA product codes are MGQ (Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic, 7); KGN (Wound Dressing With Animal-Derived Material(S), 4); FTM (Mesh, Surgical, 2).
Has Brennen Medical, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Brennen Medical, Inc. Related entities may recall under other names.
Next steps
- See all 20 Brennen Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MGQ, Brennen Medical, Inc.'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.