# K212521: Field Shield Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Kericure, Inc.
- Decided: Jul 18, 2024 after 1,073 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: 9 generations back to K914579 (1992). 81 ancestors in all.
No later device cites it as a predicate yet.
0 of 82 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092826: Asap Antimicrobial Silver Wound Dressing Gel, American Biotech Labs (2009) 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.
- K150799: Puracyn (R) Plus Duo-Care (TM) Antimicrobial Wound & Skin Hydrogel,  Puracyn (R) Plus Antimicrobial Hydrogel Professional Formula, Innovacyn, Inc. (2015) Summary page 5.
- K132326: Ionsil Gel, Virchow Biotech Pvt, Ltd. (2014) Summary page 5.
- K083103: Acryderm Antimicrobial Silver Gel Wound Dressing Model #B, Acrymed, Inc. (2009) Summary page 5.
- K140483: Asap Otc Wound Dressing Gel, Abl Medical, LLC (2014) Summary page 5.
- K190343: Silverlon Wound Contact, Burn Contact Dressings, Argentum Medical, LLC (2019) Summary page 5.

## Indications for use
Management of partial and full thickness wounds including stage I - IV pressure ulcers, venous stasis ulcers, ulcers caused by mixed vascular etiologies, Diabetic skin ulcers, 1st and 2nd degree burns, post-surgical incisions, graft sites, lacerations, skin tears, cuts and abrasions. Management of minor wounds including minor cuts, abrasions, lacerations and burns.

Source page: https://510kreport.com/device/K212521
Methodology: https://510kreport.com/methodology