510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K141580Substantially Equivalent

Sterizone Self-Contained Biological Indicator

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

K141580 is the FDA 510(k) clearance record for STERIZONE SELF-CONTAINED BIOLOGICAL INDICATOR, a class II device, cleared for Tso3, Inc. on under FDA product code FRC (Indicator, Biological Sterilization Process). FDA records list 3 510(k) clearances for Tso3, Inc. As of , FDA records show no recalls naming K141580.

Clearance record

Decision date
Received
(187 days to decision)
Product code
FRC Indicator, Biological Sterilization Process
Regulation
21 CFR 880.2800
Device class
Class II
Review panel
General Hospital
Applicant
Tso3, Inc. 512f NE 81st St., Suite 101, Vancouver WA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FRC

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