# K072068: Bioaquacare, Model C-10( Various Sizes) with and Without Gauze, Blister Packaged or in Plastic Bag Containers

- Pathway: 510(k) (Traditional)
- Applicant: Bioartificial Gel Technologies (Bagtech), Inc.
- Decided: Dec 21, 2007 after 147 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.
6 later devices descend from it; 3 cite it directly.
0 of 7 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) Xylos Corporation's XCelI® Antimicrobial Wound Dressing: named in the summary without a submission number
- (no number) AcryMed Inc.'s AcryDerm Gel Wound Dressing: named in the summary without a submission number

## Most influential descendants
- K131796: Manuka Fill Wound Dressing (2014), 3 descendants of its own
- K173911: Medline Burn and Wound Dressing (2018), 2 descendants of its own
- K254191: IWD-Gel™ (2026), 0 descendants of its own
- K190224: Medline Burn and Wound Dressing (OTC) (2019), 0 descendants of its own
- K133934: Manuka Foam HC, Manuka Foam HC (with Acrylic Adhesive Border), Manuka Foam HC (with Silicone Adhesive Border) (2014), 0 descendants of its own

## Indications for use
BioAquaCare TM is an 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. BioAquaCare TM 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 burns, 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, BioAquaCareTM is indicated for the local management of: (1) chronic wounds such as pressure ulcers, lower extremity ulcers, venous ulcers, arterial ulcers, and diabetic ulcers; and (2) 2nd degree burns and donor sites. BioAquaCare TM is intended for single use only. BioAquaCareTM is not intended for treatment of third degree burns.

Source page: https://510kreport.com/device/K072068
Methodology: https://510kreport.com/methodology