# K982116: Aquacel Hydrofiber Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Convatec, A Bristol-Myers Squibb Co.
- Decided: Sep 8, 1998 after 84 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.
60 later devices descend from it; 3 cite it directly.
0 of 61 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) Kaltostat® Wound Dressing: named in the summary without a submission number

## Most influential descendants
- K080383: Aquacel Hydrofiber Wound Dressing and AG Hydrofiber Dressing (2008), 54 descendants of its own
- K122817: Silverlon Island Wound Dressing (2014), 13 descendants of its own
- K121275: Aquacel AG Extra Hydrofiber Dressing with Silver and Strengthening Fiber (2012), 13 descendants of its own
- K070175: Aquanova Super-Absorbent Gelling Dressing, Otc (2007), 6 descendants of its own
- K143001: Silverlon Island Wound Dressing, Silverlon Wound Pad Dressing (2014), 5 descendants of its own

## Indications for use
For Over The Counter use, Aquacel Hydrofiber Wound Dressing may be used for: abrasions, lacerations, minor cuts and minor scalds and burns. Under the supervision of a health care professional, Aquacel may be used for wounds such as: leg ulcers, pressure ulcers (Stages I-IV), and diabetic ulcers; surgical wounds (post-operative, donor sites, dermatological), burns (first and second degree); management of surgical or traumatic wounds that have been left to heal by secondary intention; local management of wounds that are prone to bleeding such as wounds that have been mechanically or surgically debrided, donor sites, and traumatic wounds.

Source page: https://510kreport.com/device/K982116
Methodology: https://510kreport.com/methodology