510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K190260Substantially Equivalent

STERIZONE(R) VP4 Sterilizer

Tso3, Inc., Quebec, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K190260 is the FDA 510(k) clearance record for STERIZONE(R) VP4 Sterilizer, a class II device, cleared for Tso3, Inc. on under FDA product code PJJ (Two Or More Sterilant Sterilizer). FDA's definition for product code PJJ reads: "Intended for use in terminal sterilization of cleaned, rinsed, and dried metal and non-metal reusable medical devices in health care facilities". FDA records list 4 510(k) clearances for Tso3, Inc., from to . As of , FDA records show no recalls naming K190260.

Clearance record

Decision date
Received
(161 days to decision)
Product code
PJJ Two Or More Sterilant Sterilizer
Regulation
21 CFR 880.6860
Device class
Class II
Review panel
General Hospital
Applicant
Tso3, Inc. 2505 Ave. Dalton, Quebec, CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PJJ

Trailing 12 months

FDA records hold no clearances under product code PJJ in the trailing twelve months.

FDA records show no clearances under product code PJJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PJJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260