# K083103: Acryderm Antimicrobial Silver Gel Wound Dressing Model #B

- Pathway: 510(k) (Traditional)
- Applicant: Acrymed, Inc.
- Decided: Feb 26, 2009 after 129 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
No predicates in its family tree.
7 later devices descend from it; 5 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) AcryDerm Silver Antimicrobial Wound Gel: named in the summary without a submission number
- (no number) AcryDerm Silver Antimicrobial OTC Wound Gel: named in the summary without a submission number

## Most influential descendants
- K092826: Asap Antimicrobial Silver Wound Dressing Gel (2009), 2 descendants of its own
- K211123: LUOFUCON Silver Wound Gel, LUOFUCON Silver Antimicrobial Wound Gel (2022), 1 descendant of its own
- K251929: SilverCeuticals® Antimicrobial Wound Gel (2026), 0 descendants of its own
- K250115: Hemastyl (™) Wound Dressing (2025), 0 descendants of its own
- K212521: Field Shield Wound Dressing (2024), 0 descendants of its own

## Indications for use
Under the supervision of a healthcare professional, AcryDerm Silver Antimicrobial Wound Gel Model #B is indicated for the management of 1s and 2d degree burns, wounds such as stasis ulcers, pressure ulcers, diabetic ulcers, lacerations, abrasions, skin tears, surgical incision sites, device insertion site wounds, graft sites, and donor sites. Over the Counter Use: OTC: AcryDerm Wound Gel Model #B is indicated for the management of minor abrasions, cuts, lacerations and scalds.

Source page: https://510kreport.com/device/K083103
Methodology: https://510kreport.com/methodology