# K152519: MTR550 (Tentative) Antimicrobial Silver Wound Gel

- Pathway: 510(k) (Traditional)
- Applicant: Medical Technology Research, Inc.
- Decided: Jun 2, 2016 after 273 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: 4 generations back to K011994 (2001). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062212: Silver Shield Antimicrobial Skin and Wound Gel, Model 3015-S, Anacapa Technologies, Inc. (2006) Summary page 4.
- K110458: Silver Antimicrobial Wound Gel, Advanced Medical Solutions Limited (2011) Summary page 4.

## Indications for use
For the management of dry to low/moderate exuding wounds such as: Stage I-IV pressure ulcers Diabetic & foot ulcers Partial and full thickness wounds Graft and donor sites Post-operative surgical wounds Trauma wounds (dermal lesions, trauma injuries and incisions) 1 & 2nd degree burns Abrasions and lacerations

Source page: https://510kreport.com/device/K152519
Methodology: https://510kreport.com/methodology