# K080471: Radio Bioaquacare

- Pathway: 510(k) (Traditional)
- Applicant: Bioartificial Gel Technologies (Bagtech), Inc.
- Decided: Mar 5, 2008 after 13 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
Longest line of descent: 4 generations back to K961758 (1996). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072068: Bioaquacare, Model C-10( Various Sizes) with and Without Gauze, Blister Packaged or in Plastic Bag Containers, Bioartificial Gel Technologies (Bagtech), Inc. (2007) Summary page 1.
- K970693: Acryderm Gel Wound Dressing, Acrymed, Inc. (1997) Summary page 1.
- K052643: Epiceram, Ceragenix Corporation (2006) Summary page 1.
- K063517: Healadex-P, Healagenics, Inc. (2007)

## Indications for use
Radio BioAquaCareTM is a hydrogel wound dressing intended for the management of wounds and provides a moist environment that supports the autolytic debridement of areas of the wound that are necrotic. Radio BioAquaCare M T wound dressing provides an effective barrier to resist microbial colonization within the dressing and reduce microbial penetration through the dressing. It is intended for use with dry, light, and moderately exuding partial and full-thickness wounds such as minor bums, superficial injuries, lacerations, cuts, abrasions, incisions and surgical wounds, and skin tears. The dressing also protects against abrasion, desiccation, and external contamination. The moist environment has a cooling effect that may reduce pain. Under the direction of a health care professional, Radio BioAquaCareTM is indicated for the local management of: (1) chronic wounds such as pressure ulcers, lower extremity ulcers, venous ulcers, arterial ulcers, diabetic ulcers, radiation dermatitis, and (2) 2Md degree bums and donor sites. Radio BioAquaCareTM is intended for single use only. Radio BioAquaCare M T is not intended for treatment of third degree bums.

Source page: https://510kreport.com/device/K080471
Methodology: https://510kreport.com/methodology