# K990368: Duoderm Hydroactive Gel Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Convatec, A Bristol-Myers Squibb Co.
- Decided: Mar 26, 1999 after 46 days
- Product code: MGQ (Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
98 later devices descend from it; 1 cites it directly.
0 of 99 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Carrasyn® Hydrogel Wound Dressing: named in the summary without a submission number

## Most influential descendants
- K040019: Silverseal (2004), 97 descendants of its own
- K063069: Silvaklenz Skin and Wound Clenser Solution (2007), 73 descendants of its own
- K073547: Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and Wound Gel (2008), 66 descendants of its own
- K090206: Oculus Puracyn Antimicrobial Skin and Wound Cleanser (2009), 37 descendants of its own
- K100918: Vashe Wound Therapy System Model: 9000-0014 (2010), 31 descendants of its own

## Indications for use
For Over-The Counter Use, DuoDERM Hydroactive Gel Wound Dressing may be used for abrasions, lacerations, minor cuts, minor scalds and burns, and skin tears. Under the supervision of a healthcare provider, DuoDERM Hydroactive Gel Wound Dressing may be used for the hydration and management of partial and full thickness wounds such as pressure sores, leg ulcers, diabetic ulcers and skin conditions resulting from radiation dermatitis.

Source page: https://510kreport.com/device/K990368
Methodology: https://510kreport.com/methodology