Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Derma Sciences, Inc. — Predicate Candidate Screening
22 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
77 daysmedian FDA review time
246 days90th percentile
22clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K150985 | Medihoney Wound Gel | Derma Sciences, Inc. | 2015-11-19 | 219 | 1 |
| K133279 | MEDIHONEY WOUND DRESSINGS | Derma Sciences, Inc. | 2015-06-25 | 609 | 0 |
| K110546 | MEDIHONEY HYDROGEL SHEET DRESSINGS WITH ACTIVE LEPTOSPERMUM | Derma Sciences, Inc. | 2011-07-27 | 152 | 5 |
| K101793 | MEDIHONEY GEL DRESSING WITH ACTIVE MANUKA HONEY | Derma Sciences, Inc. | 2011-02-22 | 239 | 3 |
| K081584 | DERMA SCIENCES OTC MEDIHONEY DRESSINGS WITH ACTIVE MANUKA HO | Derma Sciences, Inc. | 2008-06-19 | 14 | 0 |
| K080315 | DERMA SCIENCES MEDIHONEY DRESSINGS WITH ACTIVE MANUKA HONEY | Derma Sciences, Inc. | 2008-04-23 | 77 | 3 |
| K072956 | MEDIHONEY PRIMARY DRESSINGS WITH ACTIVE MANUKA HONEY | Derma Sciences, Inc. | 2007-11-07 | 19 | 0 |
| K970660 | DERMAGRAN WOUND MANAGEMENT SYSTEM | Derma Sciences, Inc. | 1997-08-12 | 172 | 0 |
| K963603 | DERMAGRAN HYDROPHILIC OINTMENT | Derma Sciences, Inc. | 1996-11-27 | 79 | 0 |
| K954738 | DERMAGRAN HYDROPHILIC WOUND DRESSING | Derma Sciences, Inc. | 1995-11-02 | 17 | 0 |
| K954742 | DERMAGRAN WET DRESSING (ZINC-SALINE) | Derma Sciences, Inc. | 1995-11-02 | 17 | 0 |
| K954743 | DERMAGRAN WOUND DRESSING CLEANER W/ZINC | Derma Sciences, Inc. | 1995-11-02 | 17 | 0 |
| K954740 | DERMAGRAN WOUND DRESSING | Derma Sciences, Inc. | 1995-11-02 | 17 | 0 |
| K954739 | DERMAGRAN HYDROPHILIC OINTMENT | Derma Sciences, Inc. | 1995-11-02 | 17 | 0 |
| K954664 | DERMAGRAN (ZINC SALINE) HYDROGEL WOUND DRESSING | Derma Sciences, Inc. | 1995-11-01 | 22 | 0 |
| K954741 | DERMAGRAN WENT DRESSING (DEXTROSE-SALINE) | Derma Sciences, Inc. | 1995-11-01 | 16 | 0 |
| K951499 | DERMAGRAN HYDROPHILIC OINTMENT | Derma Sciences, Inc. | 1995-04-18 | 64 | 0 |
| K945802 | DERMAGRAN WOUND CLEANSER WITH ZINC | Derma Sciences, Inc. | 1995-02-27 | 91 | 0 |
| K944491 | DERMAGRAN HYDROPHILIC OINTMENT | Derma Sciences, Inc. | 1994-11-22 | 70 | 0 |
| K924754 | DERMAGRAN WOUND DRESSING | Derma Sciences, Inc. | 1993-05-27 | 246 | 0 |
| K913344 | DERMAGRAN WET DRESSING (ZINC-SALINE) | Derma Sciences, Inc. | 1992-07-14 | 354 | 0 |
| K914746 | DERMAGRAN WET DRESSING | Derma Sciences, Inc. | 1992-06-17 | 239 | 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