# K112800: Suntouch Topical Hemostatic Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Huizhou Foryou Medical Devices Co., Ltd.
- Decided: May 23, 2012 after 239 days
- Product code: QSY (Hemostatic Wound Dressing Without Thrombin Or Other Biologics)
- Device class: U
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K953781 (1995). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072681: Bloodstop Hemostatic Gauze; IX Hemostatic Gauze, Lifescience Plus, Inc. (2007) Summary page 6.
- K071578: Bloodstop and Bloodstop IX  Hemostatic Gauze, Models  BS-10,BS-11,BS-12,B-13, BS-IX27, BS-IX-14, Bsix-15, Bsix-17, Lifescience Plus, Inc. (2007) Summary page 6.

## Recalls of this device
- May 18, 2015 · Class II · Z-1697-2015: Coreva Health Science, LLC. is recalling ActCel Hemostatic Dressing due to customer literature and web sites promoting that it can help control bleeding from open wounds and in body cavities. ActCel i

## Indications for use
Prescription: Suntouch Topical Hemostatic Dressing is indicated for the management of topical wounds and to temporary control of external surface bleeding; All gauze are sterilized and sold directly to users after sterilization by radiation using conditions validated following ISO 11137-2: 2006. Over the Counter: Suntouch Topical Hemostatic Dressing is indicated for temporary external topical bleeding of minor cuts, minor lacerations, and it is contraindicated for internal use. All gauze are sterilized and sold directly to users after sterilization by radiation using conditions validated following ISO 11137-2: 2006.

Source page: https://510kreport.com/device/K112800
Methodology: https://510kreport.com/methodology