510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K012116Substantially Equivalent

Acryderm Silver Antimicrobial Perforated Wound Dressing

Acrymed, Inc., Portland OR / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K012116 is the FDA 510(k) clearance record for ACRYDERM SILVER ANTIMICROBIAL PERFORATED WOUND DRESSING, cleared for Acrymed, Inc. on under FDA product code FRO (Dressing, Wound, Drug). FDA records list 14 510(k) clearances for Acrymed, Inc., from to . As of , FDA records show no recalls naming K012116.

Clearance record

Decision date
Received
(68 days to decision)
Product code
FRO Dressing, Wound, Drug
Device class
Unclassified
Review panel
Unknown
Applicant
Acrymed, Inc. 12232 SW Garden Pl., Portland OR
510(k) summary
Summary
Third party review
No

Clearances, product code FRO

Trailing 12 months
19 clearances under product code FRO in the twelve months to October 2026, January 2026 the highest month at 4.
Show the numbers
Monthly 510(k) clearances under FDA product code FRO, trailing twelve months
MonthClearances
November 20251
December 20251
January 20264
February 20261
March 20263
April 20261
May 20261
June 20263
July 20260
August 20262
September 20262
October 20260