Class Class U
Field Shield Wound Dressing (K212521)
Description
Field Shield Wound Dressing by Kericure, Inc., an FDA 510(k) cleared unknown device.
Regulatory Information
Device ClassClass Class U
510(k) NumberK212521
Clearance Date2024-07-18
Clearance TypeTraditional
Product CodeFRO
FDA Database
View on FDA DatabasePredicate lineage for K212521
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Field Shield Wound Dressing (K212521) cites 6 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K150799 | Puracyn(R) Plus Duo-Care(TM) Antimicrobial Wound & Skin Hyd... | Innovacyn, Inc. | 2015 |
| K132326 | IONSIL GEL | Virchow Biotech Pvt, Ltd. | 2014 |
| K140483 | ASAP OTC WOUND DRESSING GEL | Abl Medical, LLC | 2014 |
| K092826 | ASAP ANTIMICROBIAL SILVER WOUND DRESSING GEL | American Biotech Labs | 2009 |
| K092086 | AMERIGEL WOUND DRESSING PLUS 1/2 OZ. (15G TUBE), MODEL A202... | Amerx Health Care Corp. | 2009 |
| K083103 | ACRYDERM ANTIMICROBIAL SILVER GEL WOUND DRESSING MODEL #B | Acrymed, Inc. | 2009 |
Trace the full predicate network for K212521
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.