# K082459: Acryderm Absorbent Oxygen Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Acrymed, Inc.
- Decided: Sep 19, 2008 after 24 days
- Product code: FRO (Dressing, Wound, Drug)
- 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.
No later device cites it as a predicate yet.
0 of 1 device 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) AcryDerm Advanced Wound Dressing-Noodles: named in the summary without a submission number
- (no number) OxyBand Wound Dressing: named in the summary without a submission number
- (no number) OxyBox System: named in the summary without a submission number

## Indications for use
The new oxygen enriched topical hydrophilic closed cell foam wound dressings are indicated for use in the management of acute and chronic wounds. The products are intended as a primary topical wound contact dressings for use in the management of wound exudates for wounds such as pressure ulcers, stasis ulcers, diabetic ulcers, first and second degree bums, lacerations, puncture wounds, abrasions, skin tears, surgical incision sites, device insertion site wounds, graft sites, and donor sites. Over the Counter Use: AcryDerm. Absorbent Oxygen Dressings are intended to be used on minor wounds including lacerations scrapes, skin tears, abrasions, blister wounds, and minor bums.

Source page: https://510kreport.com/device/K082459
Methodology: https://510kreport.com/methodology