# K070175: Aquanova Super-Absorbent Gelling Dressing, Otc

- Pathway: 510(k) (Traditional)
- Applicant: Medtrade Products, Ltd.
- Decided: Jul 25, 2007 after 188 days
- Product code: QSY (Hemostatic Wound Dressing Without Thrombin Or Other Biologics)
- 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: 5 generations back to K914575 (1991). 12 ancestors in all.
6 later devices descend from it; 4 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032986: Clo-Surplusp.a.D., Scion Cardio-Vascular, Inc. (2004) Summary page 6.
- K982116: Aquacel Hydrofiber Wound Dressing, Convatec, A Bristol-Myers Squibb Co. (1998) Summary page 6.
- (no number) MedTrade Products Celox Topical Hemostatic Granules: named in the summary without a submission number

## Most influential descendants
- K143124: KA01 Chitosan Wound Dressing (2015), 2 descendants of its own
- K100693: Aquanova AG Super Absorbant Dressing, Aquanova AG Antimicrobial Dressing (2010), 1 descendant of its own
- K212766: Maxiocel Chitosan Wound Dressing (2023), 0 descendants of its own
- K173005: SURECELL Gelling Fiber Wound Dressing (2018), 0 descendants of its own
- K172010: gel-e Bandage (2017), 0 descendants of its own

## Indications for use
MedTrade Products AQUANOVA Super-Absorbent Dressing OTC is indicated for minor burns, superficial cuts, lacerations and abrasions, and minor irritations of the skin. Under the supervision of a healthcare professional AQUANOVA may be used for wounds such as leg ulcers (Stages I-IV), diabetic ulcers, surgical wounds (post-operative, donor sites, dermatological), burns (first and second degree), and the management of surgical or traumatic wounds which have been left to heal by secondary intention. AQUANOVA may also be used for the local management of wounds that are prone to bleeding such as wounds that have been surgically or mechanically debrided, donor sites, and traumatic wounds. AQUANOVA can be used in the control of minor bleeding. Aditionally, AQUANOVA may be used for exudate absorption in oncology wounds (e.g. fungating cutaneous turnours, cutaneous metastases and Kaposi's sarcomas).

Source page: https://510kreport.com/device/K070175
Methodology: https://510kreport.com/methodology