510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K120828Substantially Equivalent

Biatain Silicone Ag Foam Dressing - Adhesive: 3X3 Inches, 4X4 Inches, & 5X5 Inches

MEDLINE INDUSTRIES, LP - Northfield, Plymouth MN / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K120828 is the FDA 510(k) clearance record for BIATAIN SILICONE AG FOAM DRESSING - ADHESIVE: 3X3 INCHES, 4X4 INCHES, & 5X5 INCHES, cleared for Coloplast A/S on under FDA product code FRO (Dressing, Wound, Drug). FDA records list 414 510(k) clearances for MEDLINE INDUSTRIES, LP - Northfield, from to . As of , FDA records show no recalls naming K120828.

Clearance record

Decision date
Received
(17 days to decision)
Product code
FRO Dressing, Wound, Drug
Device class
Unclassified
Review panel
Unknown
Applicant
Coloplast A/S 1601 W. River Rd. N., Plymouth MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FRO

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