510(k) · Cleared
ClearedSTERIZONE 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 Mar 13, 2018 as substantially equivalent to K153689 (Tso3, Inc., 2016) after a 102-day review. Its family tree reaches back 10 generations to 2003. 1 later device descends from it.
- Decided
- Mar 13, 2018
- Review
- 102 days
- Class
- Class II
- Product code
- PJJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K020875 (2003). 20 ancestors in all, the oldest K981625 (1999). 1 later device descends from it, 1 citing it directly.
- Root · 10 generations backK020875 TSO3 Ozone Sterilizer, Model 125LTechnologies of Sterilization With Oxone, Tso3, Inc. · 2003
- 6 generations between
- 3 generations backK141163 Sterizone SterilizerTso3, Inc. · 2014
- 2 generations backK153392 STERIZONE VP4 SterilizerTs03, Inc. · 2016
- 1 generation backK153689 STERIZONE SterilizerTso3, Inc. · 2016
- This deviceK173694 STERIZONE VP4 SterilizerTso3, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK190260 STERIZONE (R) VP4 SterilizerTso3, Inc. · 2019
Show all 10 generations
- Root · 10 generations backK020875 TSO3 Ozone Sterilizer, Model 125LTechnologies of Sterilization With Oxone, Tso3, Inc. · 2003
- 9 generations backK051595 TSO3 Ozone Sterilizer, Model 125LTso3, Inc. · 2006
- 8 generations backK090636 TSO3 Ozone Sterilizer, Model 125LTso3, Inc. · 2009
- 7 generations backK102330 Amsco V-Pro Max Low Temperature Sterilization SystemSTERIS Corporation · 2011
- 6 generations backK112760 Amsco V-Pro Max Low Temperature Sterilization SystemSTERIS Corporation · 2011
- 5 generations backK120632 Amsco V-Pro 1 Low/Plus/Max Temperature Sterilization SystemSTERIS Corporation · 2012
- 4 generations backK131120 Amsco V-Pro 1 Low, V-Pro 1 Plus, V-Pro Max Low Temperature…STERIS Corporation · 2013
- 3 generations backK141163 Sterizone SterilizerTso3, Inc. · 2014
- 2 generations backK153392 STERIZONE VP4 SterilizerTs03, Inc. · 2016
- 1 generation backK153689 STERIZONE SterilizerTso3, Inc. · 2016
- This deviceK173694 STERIZONE VP4 SterilizerTso3, Inc. · 2018
Most influential descendants
Showing 1 of 1 · See all- K190260STERIZONE (R) VP4 SterilizerTso3, Inc. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K020875 | TSO3 Ozone Sterilizer, Model 125L | Technologies of Sterilization With Oxone, Tso3, Inc. | 2003 | — |
| −9 | K051595 | TSO3 Ozone Sterilizer, Model 125L | Tso3, Inc. | 2006 | — |
| −8 | K090636 | TSO3 Ozone Sterilizer, Model 125L | Tso3, Inc. | 2009 | — |
| −7 | K102330 | Amsco V-Pro Max Low Temperature Sterilization System | STERIS Corporation | 2011 | — |
| −6 | K112760 | Amsco V-Pro Max Low Temperature Sterilization System | STERIS Corporation | 2011 | — |
| −5 | K120632 | Amsco V-Pro 1 Low/Plus/Max Temperature Sterilization System | STERIS Corporation | 2012 | — |
| −4 | K131120 | Amsco V-Pro 1 Low, V-Pro 1 Plus, V-Pro Max Low Temperature Sterilization System | STERIS Corporation | 2013 | — |
| −3 | K141163 | Sterizone Sterilizer | Tso3, Inc. | 2014 | — |
| −2 | K153392 | STERIZONE VP4 Sterilizer | Ts03, Inc. | 2016 | — |
| −1 | K153689 | STERIZONE Sterilizer | Tso3, Inc. | 2016 | — |
| 0 (this device) | K173694 | STERIZONE VP4 Sterilizer | Tso3, Inc. | 2018 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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 |
|---|---|---|---|
| * | K153689 | STERIZONE SterilizerSummary page 7…PJJ FDA Regulation: 21 CFR 880.6860 Device Classification: Class II Premarket Notification: K153689 TSO3 Inc. STERIZONE® VP4 Sterilizer Page 1 of 7 Indications The… | 2016 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K190260 | STERIZONE (R) VP4 Sterilizer | 2019 | 0 |
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 15 years and passes through 4 companies; a new generation was cleared every 1.4 years on median.
- 8 of the 20 ancestors have a recall of any class.
- Of its descendants, K190260 (Tso3, Inc., 2019) has gone furthest, with 0 descendants of its own.
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. 2018, 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 (124 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. 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/K173694 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173694: STERIZONE VP4 Sterilizer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173694
Report an extraction error
Are you the manufacturer?
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