510(k) Report

510(k) · Cleared

Cleared

TSO3 Ozone Sterilizer, Model 125L

K090636510(k) TraditionalCleared Dec 2, 2009267-day reviewClass II21 CFR 880.6860

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Tso3, Inc. · FLF Sterilizer, Ethylene-Oxide Gas

Cleared on Dec 2, 2009 as substantially equivalent to K020875 (Technologies of Sterilization With Oxone, Tso3, Inc., 2003) and 1 other predicate after a 267-day review. Its family tree reaches back 2 generations to 2003. 22 later devices descend from it.

Decided
Dec 2, 2009
Review
267 days
Class
Class II
Product code
FLF
Recalls
None
Predicates
2

Its longest line of descent runs back 2 generations to K020875 (2003). 22 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2011: 3 descendants cleared2013: 1 descendant cleared2024: 1 descendant cleared2012: 1 descendant cleared2014: 2 descendants cleared2016: 3 descendants cleared2018: 4 descendants cleared2017: 1 descendant cleared2019: 4 descendants cleared2022: 2 descendants clearedK020875 · TSO3 Ozone Sterilizer, Model 125L · Technologies of Sterilization With Oxone, Tso3, Inc. · 2003K051595 · TSO3 Ozone Sterilizer, Model 125L · Tso3, Inc. · 2006200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 5 descendants3 generations forward: 3 descendants4 generations forward: 4 descendants5 generations forward: 3 descendants6 generations forward: 2 descendants7 generations forward: 2 descendants8 generations forward: 2 descendants K051595 · TSO3 Ozone Sterilizer, Model 125L · Tso3, Inc. · 2006K020875 · TSO3 Ozone Sterilizer, Model 125L · Technologies of Sterilization With Oxone, Tso3, Inc. · 20030+5
  1. Root · 2 generations backK020875 TSO3 Ozone Sterilizer, Model 125LTechnologies of Sterilization With Oxone, Tso3, Inc. · 2003
  2. 1 generation backK051595 TSO3 Ozone Sterilizer, Model 125LTso3, Inc. · 2006
  3. This deviceK090636 TSO3 Ozone Sterilizer, Model 125LTso3, Inc. · 2009
  4. Descendant · cites it directly · 21 of its ownK102330 Amsco V-Pro Max Low Temperature Sterilization SystemSTERIS Corporation · 2011
  5. Descendant · 2 generations on · 18 of its ownK112760 Amsco V-Pro Max Low Temperature Sterilization SystemSTERIS Corporation · 2011
  6. Descendant · 2 generations on · 17 of its ownK120632 Amsco V-Pro 1 Low/Plus/Max Temperature Sterilization SystemSTERIS Corporation · 2012
  7. Descendant · 2 generations on · 16 of its ownK131120 Amsco V-Pro 1 Low, V-Pro 1 Plus, V-Pro Max Low Temperature…STERIS Corporation · 2013
  8. Descendant · 3 generations on · 8 of its ownK160433 V-PRO® 1 Plus and V-PRO® maX Low TemperatureSTERIS Corporation · 2016

Showing 5 of 22 descendants. See all descendants

Descendants cleared per year

2011: 32012: 12013: 12014: 22016: 32017: 12018: 42019: 42022: 22024: 1
2011high 4 (2018) · low 0 (2015)2026

Most influential descendants

Showing 5 of 22 · See all
  • K102330Amsco V-Pro Max Low Temperature Sterilization SystemSTERIS Corporation · 2011 · cites it directly21descendants
  • K112760Amsco V-Pro Max Low Temperature Sterilization SystemSTERIS Corporation · 2011 · 2 generations on18descendants
  • K120632Amsco V-Pro 1 Low/Plus/Max Temperature Sterilization SystemSTERIS Corporation · 2012 · 2 generations on17descendants
  • K131120Amsco V-Pro 1 Low, V-Pro 1 Plus, V-Pro Max Low Temperature Sterilization SystemSTERIS Corporation · 2013 · 2 generations on16descendants
  • K160433V-PRO® 1 Plus and V-PRO® maX Low TemperatureSTERIS Corporation · 2016 · 3 generations on8descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K020875TSO3 Ozone Sterilizer, Model 125LTechnologies of Sterilization With Oxone, Tso3, Inc.2003—
−1K051595TSO3 Ozone Sterilizer, Model 125LTso3, Inc.2006—
0 (this device)K090636TSO3 Ozone Sterilizer, Model 125LTso3, Inc.2009—
+1K102330Amsco V-Pro Max Low Temperature Sterilization SystemSTERIS Corporation2011—
+2K112760Amsco V-Pro Max Low Temperature Sterilization SystemSTERIS Corporation2011—
+2K120632Amsco V-Pro 1 Low/Plus/Max Temperature Sterilization SystemSTERIS Corporation2012—
+2K131120Amsco V-Pro 1 Low, V-Pro 1 Plus, V-Pro Max Low Temperature Sterilization SystemSTERIS Corporation2013—
+3K160433V-PRO® 1 Plus and V-PRO® maX Low TemperatureSTERIS Corporation2016—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201130
201210
201310
201420
201630
201710
201840
201940
202220
202410
FIG. 1 — Lineage of K090636, 2003–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in FLF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new FLF device

  1. #1 K192978 EOGas 4 Ethylene Oxide Gas Sterilizerscore 0.6 · 2 generations · no Class I recall
Get a 510(k) Report

What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K020875TSO3 Ozone Sterilizer, Model 125L
Summary page 2
…ation Name Sterilizer, Chemical Class 11(as per 21CFR, part 880.6860 equivalent device) Legally Marketed Equivalent Device Name(s) TSO 3 Ozone Sterilizer, model 125L (K020875) (K051595) Description of Device TS0 3 Ozone Sterilizer, model 125L is intended to sterilize medical devices that has been pre…
Technologies of Sterilization With Oxone, Tso3, Inc.2003—
*K051595TSO3 Ozone Sterilizer, Model 125L
Summary page 2
…Sterilizer, Chemical Class 11(as per 21CFR, part 880.6860 equivalent device) Legally Marketed Equivalent Device Name(s) TSO 3 Ozone Sterilizer, model 125L (K020875) (K051595) Description of Device TS0 3 Ozone Sterilizer, model 125L is intended to sterilize medical devices that has been previously cl…
Tso3, Inc.2006—

Also cleared against K020875: 1 other device →

What descends from it? (22)

See all 22

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K102330Amsco V-Pro Max Low Temperature Sterilization SystemSTERIS Corporation201121

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 3.4 years on median.
  • None of the 2 ancestors has a recall.
  • Of its descendants, K102330 (STERIS Corporation, 2011) has gone furthest, with 21 descendants of its own.
  • 1 other device also cites its predicate K020875.

How does its category compare?

All FLF devices

FLF Sterilizer, Ethylene-Oxide Gas: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · FLF

1in 2020

2009: 12015: 22017: 12020: 1
2007high 2 (2015) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FLF

Too few FLF 510(k)s in any year since 2007 to give a median.

Recalls per year · FLF

2in 2014

2009: 12012: 12013: 22014: 2
2007high 2 (2013) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FLF

4in 2021

2007: 22008: 12009: 22010: 32011: 42012: 52013: 32014: 62015: 32016: 32017: 32019: 22021: 4
2007high 6 (2014) · low 0 (2018)2025

MAUDE reports naming product code FLF, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—02
20080—01
20091—12
20100—03
20110—04
20120—15
20130—23
20140—26
20152—03
20160—03
20171—03
20180—00
20190—02
20201—00
20210—04
20220—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

TS0 3 125L Ozone Sterilizer is intended far use in the sterilization processing of reusable medical devices in health care facilities. TSQ 125L Ozone Sterilizer is designed for sterilization of both metal and non-metal medical devices at low temperatures.

TSO 3 125L Ozone Sterilizer has the ability to sterilize successfully packaged rigid and flexible lumen medical devices, including single and multi channel flexible endoscopes such as fiberoptic and video endaoscopes.

Indications for use as stated in the FDA summary.

Also cleared against K020875

1 other device cites the same predicate.

  • K051595TSO3 Ozone Sterilizer, Model 125LTso3, Inc. · 2006

More from Tso3, Inc.

10 FDA decisions under this applicant name. See the company

  • K190260STERIZONE (R) VP4 SterilizerTso3, Inc. · 2019
  • K172191STERIZONE VP4 SterilizerTso3, Inc. · 2018
  • K173694STERIZONE VP4 SterilizerTso3, Inc. · 2018
  • K153689STERIZONE SterilizerTso3, Inc. · 2016
  • K141163Sterizone SterilizerTso3, Inc. · 2014

Recent decisions in FLF

The FLF category page

  • K192978EOGas 4 Ethylene Oxide Gas SterilizerAndersen Sterilizers, Inc. · 2020
  • K170432Anprolene AN75 Ethylene Oxide Gas SterilizerAndersen Sterilizers, Inc. · 2017
  • K150646EOGas 4 Ethylene Oxide Gas SterilizerAndersen Sterilizers, Inc. · 2015
  • K1420343M Steri-Vac Sterilizer/Aerator3M Company · 2015
  • K051595TSO3 Ozone Sterilizer, Model 125LTso3, Inc. · 2006

https://510kreport.com/device/K090636 · printed Nov 4, 2026

Cite this page

510(k) Report. “K090636: TSO3 Ozone Sterilizer, Model 125L.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K090636

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026