# K121407: Oxyband Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: O2s, LLC
- Decided: Jul 9, 2012 after 60 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 summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K040683: Bioderm Sciences Wound Dressing, Bioderm Sciences, Inc. (2004). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
02S OxyBandTM Wound Dressings assist in managing wound healing. 02S OxyBandTM Wound Dressings can be used to protect light to moderate wounds including skin tears, scrapes, minor pressure sores, abrasions, blisters, lacerations, and minor burns, chafed or irritated skin. 02S OxyBandTM Wound Dressings assist in managing wound healing. 02S OxyBandTM Wound Dressings can be used to cover and protect wounds and catheter sites, or used as a secondary dressing for other wound products such as gauze, alginates, hydrogels, debridement facilitators, or a protective cover over at risk skin. Common applications include: clean closed surgical incisions, skin graft donor sites, Stage I or II pressure ulcers, pressure sores, superficial wounds such as abrasions, skin tears, and blisters, lacerations, first and second degree burns, chafed skin, skin continuously exposed to moisture, secondary dressing over gauze, alginates or hydrogels.

Source page: https://510kreport.com/device/K121407
Methodology: https://510kreport.com/methodology