510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K895422Substantially Equivalent

Tower Self Seal Sterilization Pouch

Baxter Healthcare Corporation, Deerfield Lake IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K895422 is the FDA 510(k) clearance record for TOWER SELF SEAL STERILIZATION POUCH, a class II device, cleared for Baxter Healthcare Corp on under FDA product code JOJ (Indicator, Physical/Chemical Sterilization Process). FDA records list 570 510(k) clearances for Baxter Healthcare Corp, from to . As of , FDA records show no recalls naming K895422.

Clearance record

Decision date
Received
(89 days to decision)
Product code
JOJ Indicator, Physical/Chemical Sterilization Process
Regulation
21 CFR 880.2800
Device class
Class II
Review panel
General Hospital
Applicant
Baxter Healthcare Corp One Baxter Pkwy., Deerfield Lake IL
Third party review
No

Clearances, product code JOJ

Trailing 12 months
4 clearances under product code JOJ in the twelve months to November 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code JOJ, trailing twelve months
MonthClearances
December 20251
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20261
October 20261
November 20260