# K963603: Dermagran Hydrophilic Ointment

- Pathway: 510(k) (Traditional)
- Applicant: Derma Sciences, Inc.
- Decided: Nov 27, 1996 after 79 days
- Product code: KMF (Bandage, Liquid)
- Device class: 1
- Regulation: 21 CFR 880.5090
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
13 later devices descend from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K970660: Dermagran Wound Management System (1997), 12 descendants of its own
- K080779: Irrisept Wound Cleansing System (2009), 9 descendants of its own
- K202222: Irrisept Wound Debridement and Cleansing System (2020), 7 descendants of its own
- K210536: Irrisept Antimicrobial Wound Lavage (2021), 6 descendants of its own
- K202071: SURGIPHOR Wound Irrigation System (2020), 4 descendants of its own

Source page: https://510kreport.com/device/K963603
Methodology: https://510kreport.com/methodology