# K252167: Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fiber Dressing (Prescription)

- Pathway: 510(k) (Traditional)
- Applicant: Qingdao Bright Moon Biomedical Materials Co., Ltd.
- Decided: Dec 19, 2025 after 162 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: 6 generations back to K914604 (1992). 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)
- K173675: AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver and Strengthening Fiber, Convatec Limited (2018) Summary page 5.

## Indications for use
Enhanced silver gelling fiber dressing (OTC) may be used for the management of: Abrasions Lacerations; Minor cuts; Minor scalds and burns. Extra enhanced silver gelling fiber dressing (Rx only) may be used for the management of: Partial thickness (superficial second degree) burns; Diabetic foot ulcers, leg ulcers, (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology) and pressure ulcers/sores (partial & full thickness); Surgical wounds left to heal by secondary intention such as dehisced surgical incisions; Surgical wounds that heal by primary intent such as dermatological and surgical incisions(e.g., orthopedic and vascular); Traumatic wounds; Wounds that are prone to bleeding, such as wounds that have been mechanically or surgically debrided and donor sites;

Source page: https://510kreport.com/device/K252167
Methodology: https://510kreport.com/methodology