# K183645: Silver High Performance Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Medical Solutions, Ltd.
- Decided: May 29, 2019 after 154 days
- Product code: FRO (Dressing, Wound, Drug)
- 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 K914604 (1992). 6 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080383: Aquacel Hydrofiber Wound Dressing and AG Hydrofiber Dressing, Convatec, A Division of E.R. Squibb & Sons, LLC (2008) Summary page 4.

## Most influential descendants
- K210718: LUOFUCON Extra Silver Gelling Fiber Dressing, LUOFUCON Silver Antibacterial Gelling Fiber Dressing (2022), 2 descendants of its own
- K240485: LUOFUCON® Extra Silver Gelling Fiber Dressing Plus (Prescription use),LUOFUCON® Silver Antimicrobial Gelling Fiber Dressing Plus (OTC use) (2024), 0 descendants of its own
- K221110: LUOFUCON Silver Gelling Fiber Surgical Dressing, LUOFUCON Antibacterial Gelling Fiber Cover Dressing (2024), 0 descendants of its own
- K210974: High Performance Antimicrobial Gelling Fiber with Silver (2021), 0 descendants of its own

## Recalls of this device
- May 25, 2022 · Class III · Z-1806-2022: Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21. Thi

## Indications for use
Under the supervision of a healthcare professional, Silver High Performance Dressing can be used in the management of moderate to heavily exuding chronic and acute wounds. The dressing is indicated for use on the following wounds: • Pressure ulcers (partial and full thickness) • Leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology) • Diabetic foot ulcers • Surgical wounds that heal by primary intent such as dermatological and surgical incisions • Surgical wounds left to heal by secondary intention such as dehisced surgical incisions and donor sites • Traumatic wounds

Source page: https://510kreport.com/device/K183645
Methodology: https://510kreport.com/methodology