# K211943: Microlyte Ag/Lidocaine

- Pathway: 510(k) (Traditional)
- Applicant: Imbed Biosciences
- Decided: Oct 17, 2024 after 1,212 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 K914604 (1992). 25 ancestors in all.
No later device cites it as a predicate yet.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053476: Allwound, At Squared, LLC (2006) Summary page 5.
- K153756: Microlyte Ag, Imbed Biosciences, Inc. (2016) Summary page 5.
- K092086: Amerigel Wound Dressing Plus 1/2 OZ. (15G Tube), Model A2025; 1 OZ. (30G Tube), Model A2026; 3 OZ (90G Tube),Model A2027, Amerx Health Care Corp. (2009) Summary page 5.

## Indications for use
Under the supervision of a healthcare professional, Microlyte® Ag/Lidocaine Wound Dressing may be used for the management of partial and full thickness wounds including diabetic foot ulcers, venous stasis ulcers, pressure ulcers, ischemic ulcers, surgical wounds, post-surgical incisions, donor sites, debrided partial thickness wounds, traumatic wounds, first degree burns, partial thickness burns, abrasions and lacerations.

Source page: https://510kreport.com/device/K211943
Methodology: https://510kreport.com/methodology