# K043063: Oxyband Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Oxyband Technologies, Inc.
- Decided: Mar 24, 2005 after 139 days
- Product code: NAD (Dressing, Wound, Occlusive)
- Device class: 1
- Regulation: 21 CFR 878.4020
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K811291 (1981). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973036: 3M Tegaderm Transparent Dressing, 3M Tegaderm Transparent Dressing (First Aid Delivery), 3M Tegaderm HP Transparent Dres, 3M Healthcare (1997) Summary page 1.
- K973312: Transparent Film Dressing, Intelligent Film Dressing, Innovative Technologies, Ltd. (1997) Summary page 1.
- K020781: Wet Chamber, Kinetic Concepts, Inc. (2002) Summary page 1.

## Indications for use
OxyBand TM Wound Dressings are intended to provide a moist environment to facilitate the normal wound healing process. OxyBand TM 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. The OxyBand TM Wound Dressings are indicated for: clean closed surgical incisions, skin graft donor sites, Stage I or I1 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. OxyBand TM Wound Dressings are intended to protect light to moderate wounds, including skin tears, scrapes, minor pressure sores, abrasions, blisters, lacerations, minor bums, to protect chafed or irritated skin or skin continuously exposed to moisture, and to create a moist environment for wound healing. OxyBand TM Wound Dressings are intended to provide a moist environment to facilitate the normal wound healing process. OxyBand TM 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. The OxyBand TM Wound Dressings are indicated for: clean closed surgical incisions, skin graft donor sites, Stage I or I1 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. OxyBand TM Wound Dressings are intended to protect light to moderate wounds, including skin tears, scrapes, minor pressure sores, abrasions, blisters, lacerations, minor bums, to protect chafed or irritated skin or skin continuously exposed to moisture, and to create a moist environment for wound healing.

Source page: https://510kreport.com/device/K043063
Methodology: https://510kreport.com/methodology