Home / 510(k) Clearances / K090636

510(k) K090636

TSO3 OZONE STERILIZER, MODEL 125L by Tso3, Inc. — Product Code FLF

K090636 is an FDA 510(k) premarket notification submitted by Tso3, Inc. for the device "TSO3 OZONE STERILIZER, MODEL 125L". The FDA issued a decision of Substantially Equivalent on December 2, 2009. The device falls under product code FLF (Sterilizer, Ethylene-Oxide Gas), a Class II device regulated under 21 CFR 880.6860. Tso3, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 2, 2009
Date Received
March 10, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sterilizer, Ethylene-Oxide Gas
Device Class
Class II
Regulation Number
880.6860
Review Panel
HO
Submission Type

Other clearances by Tso3, Inc.

  • K190260 — STERIZONE(R) VP4 Sterilizer (July 19, 2019)
  • K172191 — STERIZONE VP4 Sterilizer (May 9, 2018)
  • K173694 — STERIZONE VP4 Sterilizer (March 13, 2018)
  • K153689 — STERIZONE Sterilizer (June 30, 2016)
  • K141698 — STERIZONE CHEMICAL INDICATOR (December 17, 2014)
  • K141163 — STERIZONE STERILIZER (December 17, 2014)
  • K141580 — STERIZONE SELF-CONTAINED BIOLOGICAL INDICATOR (December 17, 2014)
  • K080198 — TSO3 OZONE STERILIZATION WRAP (May 30, 2008)
  • K051595 — TSO3 OZONE STERILIZER, MODEL 125L (July 26, 2006)

Other clearances for product code FLF

  • K192978 — EOGas 4 Ethylene Oxide Gas Sterilizer (November 12, 2020)
  • K170432 — Anprolene AN75 Ethylene Oxide Gas Sterilizer (October 31, 2017)
  • K150646 — EOGas 4 Ethylene Oxide Gas Sterilizer (November 18, 2015)
  • K142034 — 3M STERI-VAC STERILIZER/AERATOR (January 8, 2015)
  • K051595 — TSO3 OZONE STERILIZER, MODEL 125L (July 26, 2006)
  • K020875 — TSO3 OZONE STERILIZER, MODEL 125L (August 26, 2003)
  • K014013 — H & W HOSPITAL ETHYLENE OXIDE STERILIZER CONTROL SYSTEM (June 25, 2003)
  • K023290 — STERRAD 50 & STERRAD 100S STERILIZERS (April 3, 2003)
  • K905119 — PLAZLYTE(TM) (December 22, 1994)
  • K923442 — ABTOX PLAZLYTE PROCESS MONITOR (December 22, 1994)

FDA data resources