Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Brennen Medical, Inc. · Predicate Candidate Screening
17 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
84 daysmedian FDA review time
258 days90th percentile
17clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K050086 | BRENNEN MEDICAL SILVER GLUCAN WOUND DRESSING | Brennen Medical, Inc. | 2006-02-17 | 400 | 0 |
| K030460 | MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX | Brennen Medical, Inc. | 2003-03-07 | 23 | 0 |
| K021835 | BRENNEN MEDICAL SURGICAL MESH, GLUCAMESH/GLUCATEX | Brennen Medical, Inc. | 2002-10-17 | 135 | 0 |
| K002078 | BETA GLUCAN GEL (MACROPRO GEL) | Brennen Medical, Inc. | 2000-10-02 | 84 | 0 |
| K002077 | GLUCANPRO CREAM | Brennen Medical, Inc. | 2000-10-02 | 84 | 0 |
| K000519 | GLUCANPRO | Brennen Medical, Inc. | 2000-05-01 | 75 | 0 |
| K000518 | MACROPRO GEL | Brennen Medical, Inc. | 2000-05-01 | 75 | 0 |
| K982825 | BRENNEN MEDICAL BETA GLUCAN GEL | Brennen Medical, Inc. | 1998-11-06 | 87 | 0 |
| K982403 | BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX | Brennen Medical, Inc. | 1998-09-22 | 74 | 0 |
| K980962 | BRENNEN MEDICAL BETA GLUCAN CREAM, MACROPRO | Brennen Medical, Inc. | 1998-07-29 | 135 | 0 |
| K964241 | BRENNEN MEDICAL GLUCAN II WOUND DRESSING | Brennen Medical, Inc. | 1996-12-12 | 49 | 0 |
| K963128 | NOVAGEL SILICONE GEL SHEETING | Brennen Medical, Inc. | 1996-12-05 | 115 | 0 |
| K950032 | MEDISKIN(R) SS, ZENODERM BIOLOGICAL WOUND DRESSING | Brennen Medical, Inc. | 1995-06-28 | 175 | 0 |
| K950281 | MESH MATRIX WOUND DRESSING | Brennen Medical, Inc. | 1995-04-13 | 79 | 0 |
| K935189 | E-Z DERM BIOSYNTHETIC WOUND DRESSING | Brennen Medical, Inc. | 1994-07-11 | 258 | 0 |
| K941125 | NOVAGEL SILICONE GEL SHEETING | Brennen Medical, Inc. | 1994-05-31 | 83 | 0 |
| K935060 | BRENNEN MEDICAL STERILE SALINE SOLUTION | Brennen Medical, Inc. | 1994-01-10 | 82 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda