# K153756: Microlyte Ag

- Pathway: 510(k) (Traditional)
- Applicant: Imbed Biosciences, Inc.
- Decided: Aug 4, 2016 after 218 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 K914604 (1992). 12 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 14 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 5.
- K002599: Modification to Acryderm Silver Antimicrobial Wound Dressing, Models 1041, 1042, 1043, 1044, 1045, Acrymed, Inc. (2000) Summary page 5.
- K981299: Silverlon Contact Wound Dressing, Argentum International, LLC (1998) Summary page 5.

## Most influential descendants
- K211943: Microlyte Ag/Lidocaine (2024), 0 descendants of its own

## Indications for use
Under the supervision of a healthcare professional, Microlyte™ Ag wound dressing may be used for the management of: -Wounds, -Partial and full thickness wounds including pressure ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns, abrasions and lacerations, donor sites and surgical wounds, -May be used over debrided and grafted partial thickness wounds. For over-the-counter use, Microlyte™ Ag wound dressing may be used for: abrasions, lacerations, minor cuts, and minor scalds and burns.

Source page: https://510kreport.com/device/K153756
Methodology: https://510kreport.com/methodology