510(k) · Cleared
ClearedTSO3 Ozone Sterilizer, Model 125L
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Technologies of Sterilization With Oxone, Tso3, Inc. · FLF Sterilizer, Ethylene-Oxide Gas
Cleared on Aug 26, 2003 after a 526-day review. The FDA summary names its predicate without a number. 24 later devices descend from it.
- Decided
- Aug 26, 2003
- Review
- 526 days
- Class
- Class II
- Product code
- FLF
- Recalls
- None
- Predicates
- 0
24 later devices descend from it, 2 citing it directly.
- This deviceK020875 TSO3 Ozone Sterilizer, Model 125LTechnologies of Sterilization With Oxone, Tso3, Inc. · 2003
- Descendant · cites it directly · 23 of its ownK051595 TSO3 Ozone Sterilizer, Model 125LTso3, Inc. · 2006
- Descendant · cites it directly · 22 of its ownK090636 TSO3 Ozone Sterilizer, Model 125LTso3, Inc. · 2009
- Descendant · 2 generations on · 21 of its ownK102330 Amsco V-Pro Max Low Temperature Sterilization SystemSTERIS Corporation · 2011
- Descendant · 3 generations on · 18 of its ownK112760 Amsco V-Pro Max Low Temperature Sterilization SystemSTERIS Corporation · 2011
- Descendant · 3 generations on · 17 of its ownK120632 Amsco V-Pro 1 Low/Plus/Max Temperature Sterilization SystemSTERIS Corporation · 2012
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K051595TSO3 Ozone Sterilizer, Model 125LTso3, Inc. · 2006 · cites it directly23descendants
- K090636TSO3 Ozone Sterilizer, Model 125LTso3, Inc. · 2009 · cites it directly22descendants
- K102330Amsco V-Pro Max Low Temperature Sterilization SystemSTERIS Corporation · 2011 · 2 generations on21descendants
- K112760Amsco V-Pro Max Low Temperature Sterilization SystemSTERIS Corporation · 2011 · 3 generations on18descendants
- K120632Amsco V-Pro 1 Low/Plus/Max Temperature Sterilization SystemSTERIS Corporation · 2012 · 3 generations on17descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K020875 | TSO3 Ozone Sterilizer, Model 125L | Technologies of Sterilization With Oxone, Tso3, Inc. | 2003 | — |
| +1 | K051595 | TSO3 Ozone Sterilizer, Model 125L | Tso3, Inc. | 2006 | — |
| +1 | K090636 | TSO3 Ozone Sterilizer, Model 125L | Tso3, Inc. | 2009 | — |
| +2 | K102330 | Amsco V-Pro Max Low Temperature Sterilization System | STERIS Corporation | 2011 | — |
| +3 | K112760 | Amsco V-Pro Max Low Temperature Sterilization System | STERIS Corporation | 2011 | — |
| +3 | K120632 | Amsco V-Pro 1 Low/Plus/Max Temperature Sterilization System | STERIS Corporation | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 4 | 0 |
| 2019 | 4 | 0 |
| 2022 | 2 | 0 |
| 2024 | 1 | 0 |
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 K192978 EOGas 4 Ethylene Oxide Gas Sterilizerscore 0.6 · 2 generations · no Class I recall
What was it cleared against? (1)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | STERRAD 100S Sterilization System Named without a submission number |
What descends from it? (24)
See all 242 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K051595 (Tso3, Inc., 2006) has gone furthest, with 23 descendants of its own.
How does its category compare?
All FLF devicesFLF Sterilizer, Ethylene-Oxide Gas: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FLF
1in 2020
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
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FLF
4in 2021
MAUDE reports naming product code FLF, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 2 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 1 | — | 1 | 2 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 4 |
| 2012 | 0 | — | 1 | 5 |
| 2013 | 0 | — | 2 | 3 |
| 2014 | 0 | — | 2 | 6 |
| 2015 | 2 | — | 0 | 3 |
| 2016 | 0 | — | 0 | 3 |
| 2017 | 1 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 4 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The TSO3-Model 125L is an Ozone Sterilizer intended for use in the sterilization processing of reusable medical devices in Health Care Facilities. The TSO3 Model 125L Ozone Sterilizer is designed for sterilization of both metal and non-metal medical devices at low temperatures. The sterilization cycle operates at very low pressure and low temperatures, consequently it is suitable for processing medical devices sensitive to heat and moisture. The…
Read the full statement (195 words)
The TSO3-Model 125L is an Ozone Sterilizer intended for use in the sterilization processing of reusable medical devices in Health Care Facilities. The TSO3 Model 125L Ozone Sterilizer is designed for sterilization of both metal and non-metal medical devices at low temperatures. The sterilization cycle operates at very low pressure and low temperatures, consequently it is suitable for processing medical devices sensitive to heat and moisture.
The TS03-125L Ozone Sterilizer is designed to sterilize instruments and devices with diffusion-restricted spaces, such as the hinged portion of forceps and scissors.
The TS03-125L Ozone Sterilizer is also designed to process medical devices having a single stainless steel lumen with:
- an inside diameter of 2 mm or larger and a length of 250 mm or shorter,
- an inside diameter of 3 mm or larger and a length of 470 mm or shorter;
- an inside diameter of 4 mm or larger and a length of 600 mm or shorter.
Note: Testing conducted employing half cycle with a SAL of 10⁻⁶ with no survivors.
The packaging compatible with the TSO3-Model 125L Ozone Sterilizer are TSO3 sterilization pouch and rigid anodized aluminum containers using disposable cellulose filter paper.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K020875 · printed Nov 4, 2026
Cite this page
510(k) Report. “K020875: 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/K020875
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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