510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K820435Substantially Equivalent

Baxa Addiseal

Baxa Corp., Sub. of Cook Group, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K820435 is the FDA 510(k) clearance record for BAXA ADDISEAL, a class II device, cleared for Baxa Corp., Sub. of Cook Group, Inc. on under FDA product code KPE (Container, I.V.). FDA records list 16 510(k) clearances for Baxa Corp., Sub. of Cook Group, Inc., from to . As of , FDA records show no recalls naming K820435.

Clearance record

Decision date
Received
(19 days to decision)
Product code
KPE Container, I.V.
Regulation
21 CFR 880.5025
Device class
Class II
Review panel
General Hospital
Applicant
Baxa Corp., Sub. of Cook Group, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KPE

Trailing 12 months
3 clearances under product code KPE in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KPE, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20261
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260