# K143335: Roosin Silver Calcium Alginate Dressing (Prescription), Roosin Alginate Dressing with Preservative (OTC)

- Pathway: 510(k) (Traditional)
- Applicant: Roosin Medical Devices Co., Ltd.
- Decided: Jun 1, 2015 after 193 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: 5 generations back to K914579 (1992). 14 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120181: Lufucon Silver Alginate Dressing 50X50MM, Lufucon Silver Alginate Dressing 100X100MM, Lufucon Silver Dressing 200X100MM, Huizhou Foryou Medical Devices Co., Ltd. (2013) Summary page 4.

## Most influential descendants
- K230190: Polyver Silver Alginate Dressing (Prescription and OTC) (2023), 0 descendants of its own

## Indications for use
Prescription: Roosin Silver Alginate Dressing is indicated for the management of moderate to heavily exuding partial to full thickness wounds, including postoperative wounds, trauma wounds, leg ulcers, pressure ulcers, diabetic ulcers, graft and donor sites OTC: First aid to help in minor abrasions, minor cuts, lacerations, scrapes, minor scalds and burns.

Source page: https://510kreport.com/device/K143335
Methodology: https://510kreport.com/methodology