510(k) · Cleared
ClearedSTERIZONE (R) VP4 Sterilizer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tso3, Inc. · PJJ Two Or More Sterilant Sterilizer
Cleared on Jul 19, 2019 as substantially equivalent to K173694 (Tso3, Inc., 2018) after a 161-day review. Its family tree reaches back 11 generations to 2003.
- Decided
- Jul 19, 2019
- Review
- 161 days
- Class
- Class II
- Product code
- PJJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K020875 (2003). 21 ancestors in all, the oldest K981625 (1999). No later device cites it as a predicate yet.
- Root · 11 generations backK020875 TSO3 Ozone Sterilizer, Model 125LTechnologies of Sterilization With Oxone, Tso3, Inc. · 2003
- 7 generations between
- 3 generations backK153392 STERIZONE VP4 SterilizerTs03, Inc. · 2016
- 2 generations backK153689 STERIZONE SterilizerTso3, Inc. · 2016
- 1 generation backK173694 STERIZONE VP4 SterilizerTso3, Inc. · 2018
- This deviceK190260 STERIZONE (R) VP4 SterilizerTso3, Inc. · 2019
Show all 11 generations
- Root · 11 generations backK020875 TSO3 Ozone Sterilizer, Model 125LTechnologies of Sterilization With Oxone, Tso3, Inc. · 2003
- 10 generations backK051595 TSO3 Ozone Sterilizer, Model 125LTso3, Inc. · 2006
- 9 generations backK090636 TSO3 Ozone Sterilizer, Model 125LTso3, Inc. · 2009
- 8 generations backK102330 Amsco V-Pro Max Low Temperature Sterilization SystemSTERIS Corporation · 2011
- 7 generations backK112760 Amsco V-Pro Max Low Temperature Sterilization SystemSTERIS Corporation · 2011
- 6 generations backK120632 Amsco V-Pro 1 Low/Plus/Max Temperature Sterilization SystemSTERIS Corporation · 2012
- 5 generations backK131120 Amsco V-Pro 1 Low, V-Pro 1 Plus, V-Pro Max Low Temperature…STERIS Corporation · 2013
- 4 generations backK141163 Sterizone SterilizerTso3, Inc. · 2014
- 3 generations backK153392 STERIZONE VP4 SterilizerTs03, Inc. · 2016
- 2 generations backK153689 STERIZONE SterilizerTso3, Inc. · 2016
- 1 generation backK173694 STERIZONE VP4 SterilizerTso3, Inc. · 2018
- This deviceK190260 STERIZONE (R) VP4 SterilizerTso3, Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K020875 | TSO3 Ozone Sterilizer, Model 125L | Technologies of Sterilization With Oxone, Tso3, Inc. | 2003 | — |
| −10 | K051595 | TSO3 Ozone Sterilizer, Model 125L | Tso3, Inc. | 2006 | — |
| −9 | K090636 | TSO3 Ozone Sterilizer, Model 125L | Tso3, Inc. | 2009 | — |
| −8 | K102330 | Amsco V-Pro Max Low Temperature Sterilization System | STERIS Corporation | 2011 | — |
| −7 | K112760 | Amsco V-Pro Max Low Temperature Sterilization System | STERIS Corporation | 2011 | — |
| −6 | K120632 | Amsco V-Pro 1 Low/Plus/Max Temperature Sterilization System | STERIS Corporation | 2012 | — |
| −5 | K131120 | Amsco V-Pro 1 Low, V-Pro 1 Plus, V-Pro Max Low Temperature Sterilization System | STERIS Corporation | 2013 | — |
| −4 | K141163 | Sterizone Sterilizer | Tso3, Inc. | 2014 | — |
| −3 | K153392 | STERIZONE VP4 Sterilizer | Ts03, Inc. | 2016 | — |
| −2 | K153689 | STERIZONE Sterilizer | Tso3, Inc. | 2016 | — |
| −1 | K173694 | STERIZONE VP4 Sterilizer | Tso3, Inc. | 2018 | — |
| 0 (this device) | K190260 | STERIZONE (R) VP4 Sterilizer | Tso3, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 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 PJJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
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 |
|---|---|---|---|
| * | K173694 | STERIZONE VP4 SterilizerSummary page 7…rilizer Technical Method: Dual sterilant sterilizer using hydrogen peroxide and ozone as the sterilant Legally Marketed Predicate Device Name STERIZONE® VP4 Sterilizer (K173694) TSO3, Inc. K190260 STERIZONE® VP4 Sterilizer Page 1 of 7 Device Description The STER… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
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 16 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
- 8 of the 21 ancestors have a recall of any class.
How does its category compare?
All PJJ devicesPJJ Two Or More Sterilant Sterilizer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · PJJ
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · PJJ
Too few PJJ 510(k)s in any year since 2007 to give a median.
Recalls per year · PJJ
No recall names PJJ since 2007.
Adverse event reports per year · PJJ
6in 2017
MAUDE reports naming product code PJJ, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 6 |
| 2018 | 2 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 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 STERIZONE® VP4 Sterilizer is intended for use in terminal sterilization of cleaned, rinsed, and dried metal and non- metal reusable medical devices in health care facilities. The single pre-set cycle of the STERIZONE® VP4 Sterilizer uses hydrogen peroxide and ozone. The injection of vaporized hydrogen peroxide is followed by the injection of ozone, which reacts with residual hydrogen peroxide to form hydroxyl radicals. Sterilization efficacy was…
Read the full statement (135 words)
The STERIZONE® VP4 Sterilizer is intended for use in terminal sterilization of cleaned, rinsed, and dried metal and non- metal reusable medical devices in health care facilities.
The single pre-set cycle of the STERIZONE® VP4 Sterilizer uses hydrogen peroxide and ozone. The injection of vaporized hydrogen peroxide is followed by the injection of ozone, which reacts with residual hydrogen peroxide to form hydroxyl radicals.
Sterilization efficacy was demonstrated using a representative sample of one or more device types and packaging, in nine separate validation loads, as described in Table 1 [refer to continuation pages 2 - 4 of this form]. The load to be processed should be maintained between 20°C to 26°C (68°F to 78°F). Total load weight shall not exceed 75 lb, inclusive of the containers/packaging weight but excluding the 25 lb loading rack.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190260 · printed Nov 4, 2026
Cite this page
510(k) Report. “K190260: STERIZONE (R) VP4 Sterilizer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K190260
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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