510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K083355Substantially Equivalent

Wound Wash Saline, 210 Ml, Model B8552, Wound Wash Saline, 90 Ml, Model B8553

Blairex Laboratories, Inc., Columbus IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K083355 is the FDA 510(k) clearance record for WOUND WASH SALINE, 210 ML, MODEL B8552, WOUND WASH SALINE, 90 ML, MODEL B8553, cleared for Blairex Laboratories, Inc. on under FDA product code FRO (Dressing, Wound, Drug). FDA records list 3 510(k) clearances for Blairex Laboratories, Inc., from to . As of , FDA records show no recalls naming K083355.

Clearance record

Decision date
Received
(46 days to decision)
Product code
FRO Dressing, Wound, Drug
Device class
Unclassified
Review panel
Unknown
Applicant
Blairex Laboratories, Inc. 1600 Brian Dr., Columbus IN
510(k) summary
Summary PDF
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