510(k) · Cleared
ClearedSTERIZONE 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 Jun 30, 2016 as substantially equivalent to K141163 (Tso3, Inc., 2014) and 1 other predicate after a 190-day review. Its family tree reaches back 9 generations to 2003. 2 later devices descend from it.
- Decided
- Jun 30, 2016
- Review
- 190 days
- Class
- Class II
- Product code
- PJJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K020875 (2003). 19 ancestors in all, the oldest K981625 (1999). 2 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK020875 TSO3 Ozone Sterilizer, Model 125LTechnologies of Sterilization With Oxone, Tso3, Inc. · 2003
- 5 generations between
- 3 generations backK131120 Amsco V-Pro 1 Low, V-Pro 1 Plus, V-Pro Max Low Temperature…STERIS Corporation · 2013
- 2 generations backK141163 Sterizone SterilizerTso3, Inc. · 2014
- 1 generation backK153392 STERIZONE VP4 SterilizerTs03, Inc. · 2016
- This deviceK153689 STERIZONE SterilizerTso3, Inc. · 2016
- Descendant · cites it directly · 1 of its ownK173694 STERIZONE VP4 SterilizerTso3, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK190260 STERIZONE (R) VP4 SterilizerTso3, Inc. · 2019
Show all 9 generations
- Root · 9 generations backK020875 TSO3 Ozone Sterilizer, Model 125LTechnologies of Sterilization With Oxone, Tso3, Inc. · 2003
- 8 generations backK051595 TSO3 Ozone Sterilizer, Model 125LTso3, Inc. · 2006
- 7 generations backK090636 TSO3 Ozone Sterilizer, Model 125LTso3, Inc. · 2009
- 6 generations backK102330 Amsco V-Pro Max Low Temperature Sterilization SystemSTERIS Corporation · 2011
- 5 generations backK112760 Amsco V-Pro Max Low Temperature Sterilization SystemSTERIS Corporation · 2011
- 4 generations backK120632 Amsco V-Pro 1 Low/Plus/Max Temperature Sterilization SystemSTERIS Corporation · 2012
- 3 generations backK131120 Amsco V-Pro 1 Low, V-Pro 1 Plus, V-Pro Max Low Temperature…STERIS Corporation · 2013
- 2 generations backK141163 Sterizone SterilizerTso3, Inc. · 2014
- 1 generation backK153392 STERIZONE VP4 SterilizerTs03, Inc. · 2016
- This deviceK153689 STERIZONE SterilizerTso3, Inc. · 2016
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K020875 | TSO3 Ozone Sterilizer, Model 125L | Technologies of Sterilization With Oxone, Tso3, Inc. | 2003 | — |
| −8 | K051595 | TSO3 Ozone Sterilizer, Model 125L | Tso3, Inc. | 2006 | — |
| −7 | K090636 | TSO3 Ozone Sterilizer, Model 125L | Tso3, Inc. | 2009 | — |
| −6 | K102330 | Amsco V-Pro Max Low Temperature Sterilization System | STERIS Corporation | 2011 | — |
| −5 | K112760 | Amsco V-Pro Max Low Temperature Sterilization System | STERIS Corporation | 2011 | — |
| −4 | K120632 | Amsco V-Pro 1 Low/Plus/Max Temperature Sterilization System | STERIS Corporation | 2012 | — |
| −3 | K131120 | Amsco V-Pro 1 Low, V-Pro 1 Plus, V-Pro Max Low Temperature Sterilization System | STERIS Corporation | 2013 | — |
| −2 | K141163 | Sterizone Sterilizer | Tso3, Inc. | 2014 | — |
| −1 | K153392 | STERIZONE VP4 Sterilizer | Ts03, Inc. | 2016 | — |
| 0 (this device) | K153689 | STERIZONE Sterilizer | Tso3, Inc. | 2016 | — |
| +1 | K173694 | STERIZONE VP4 Sterilizer | Tso3, Inc. | 2018 | — |
| +2 | 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 |
|---|---|---|
| 2018 | 1 | 0 |
| 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K141163 | Sterizone SterilizerSummary page 5…ne Oxide Gas Sterilizer Class II (as per 21CFR, part 880.6860 equivalent device) Product Code: PJJ Legally Marketed Equivalent Device Name(s) STERIZONE® VP4 Sterilizer (K141163 and K153392) Page 1… | 2014 |
| * | K153392 | STERIZONE VP4 Sterilizer Cleared while this submission was under review Summary page 5…Sterilizer Class II (as per 21CFR, part 880.6860 equivalent device) Product Code: PJJ Legally Marketed Equivalent Device Name(s) STERIZONE® VP4 Sterilizer (K141163 and K153392) Page 1… | 2016 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173694 | STERIZONE VP4 Sterilizer | 2018 | 1 |
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 13 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
- 8 of the 19 ancestors have a recall of any class.
- Of its descendants, K173694 (Tso3, Inc., 2018) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K141163.
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. 2016, 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 (638 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 lbs, inclusive of the containers/packaging weight but excluding the 25 lbs loading rack.
Table 1. Description of the nine validation loads
Validation load #1 consisted of general medical instruments, representing the following geometries: Clamp, Serrated surface, Box-lock, Handle, Button, Pivot hinge, and Stopcock. Type of packaging used: wrapped plastic tray, including silicone mats and brackets, and Pouch. General medical instruments were spread out over three trays, six pouches and one wrapped instrument. Load weight: 11 lb.
Validation load #2 consisted of general medical instruments, representing the following geometries: Gliding mechanism, Hinges and screws, Serrated surface, Luer-lock, Spring, and Rigid non-lumen scopes. Type of packaging used: wrapped plastic and aluminum tray, including silicone mats and brackets, rigid aluminum container and Pouch. General medical instruments were spread out over one container, three trays, and six pouches. Load weight: 20 lb.
Validation load #3 consisted of three single channel flexible endoscopes (Ureteroscope) with inside diameter of 1.0 mm and length of 850 mm, packaged individually in wrapped trays or containers, including appropriate silicone brackets or mats. Eight general medical instruments, each packaged in a pouch, were added. Load weight: 23 lb.
Validation load #4 consisted of up to 15 rigid or semi-rigid channeled instruments in the presence of other packaged medical devices. Three double channel semi-rigid endoscopes (ureteroscope – 0.7 mm × 500 mm and 1.1 mm × 500 mm) were packaged individually in wrapped trays or containers including appropriate silicone brackets or mats. Additional rigid channeled instruments or stainless steel rigid lumens were added to each package. Two additional general medical instruments, each packaged in a pouch, were added. Load weight: 19 lb.
Validation load #5 consisted in two single channel flexible endoscopes; one Ureteroscope with inside diameter of 1.0 mm and length of 850 mm, and a Bronchoscope with inside diameter of 1.8 mm and length of 830 mm, and one double channel semi-rigid endoscope (ureteroscope – 0.7 mm × 500 mm and 1.1 mm × 500 mm), packaged individually in wrapped trays or containers including appropriate silicone brackets or mats. No additional item was added. Load weight: 21 lb.
Validation load #6 consisted of general medical instruments, representing the following geometries: Distal end (swivel parts), Hinge with screw, and Cannula. General medical instruments packaged in one aluminum sterilization container. Load weight: 9 lb.
Validation load #7 consisted of general medical instruments, representing the following geometries: Box-lock hinge, Pivot hinge, and Luer-lock. General medical instruments, spread out over three aluminum sterilization containers, each weighting 25 lb. Load weight: 75 lb.
Validation load #8 consisted of two double-channel flexible endoscopes (Ureteroscope) with inside diameter of 1 mm and lengths of 850 and 989 mm; and one single-channel flexible endoscopes (Ureteroscope) with inside diameter of 1 mm and length of 850 mm, packaged individually in wrapped plastic sterilization trays, including appropriate silicone brackets or mats. Load weight: 16 lb.
Validation load #9 consisted of one multi-channel flexible endoscope, with no more than 4 channels (Video Colonoscope), with inside diameters of 1.2 or more and lengths of 1955 mm or less, or 1.45 or more and lengths of 3500 mm or less; packaged in aluminium sterilization container. Load weight: 17 lb.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K153689 · printed Nov 5, 2026
Cite this page
510(k) Report. “K153689: STERIZONE Sterilizer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K153689
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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