510(k) · Cleared
ClearedV-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
STERIS Corporation · MLR Sterilizer, Chemical
Cleared on Jan 3, 2019 as substantially equivalent to K172319 (STERIS Corporation, 2018) after a 107-day review. Its family tree reaches back 10 generations to 2003. 4 later devices descend from it.
- Decided
- Jan 3, 2019
- Review
- 107 days
- Class
- Class II
- Product code
- MLR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K020875 (2003). 15 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 10 generations backK020875 TSO3 Ozone Sterilizer, Model 125LTechnologies of Sterilization With Oxone, Tso3, Inc. · 2003
- 6 generations between
- 3 generations backK160433 V-PRO® 1 Plus and V-PRO® maX Low TemperatureSTERIS Corporation · 2016
- 2 generations backK162413 AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1…STERIS Corporation · 2017 · Recalled
- 1 generation backK172319 AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1…STERIS Corporation · 2018 · Recalled
- This deviceK182568 V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low…STERIS Corporation · 2019
- Descendant · cites it directly · 2 of its ownK190917 V-PRO 60 a Low Tempurature Strilization Systems, V-PRO s2 Low…STERIS Corporation · 2019
- Descendant · 2 generations on · 1 of its ownK222543 AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature…Steris · 2022
- Descendant · 2 generations on · 0 of its ownK222849 AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature…Steris · 2022
- Descendant · cites it directly · 0 of its ownK190027 SteriStayToul Meditech AB · 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 backK160433 V-PRO® 1 Plus and V-PRO® maX Low TemperatureSTERIS Corporation · 2016
- 2 generations backK162413 AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1…STERIS Corporation · 2017 · Recalled
- 1 generation backK172319 AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1…STERIS Corporation · 2018 · Recalled
- This deviceK182568 V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low…STERIS Corporation · 2019
Most influential descendants
Showing 4 of 4 · See all- K190917V-PRO 60 a Low Tempurature Strilization Systems, V-PRO s2 Low Temperature Sterilization…STERIS Corporation · 2019 · cites it directly2descendants
- K222543AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2…Steris · 2022 · 2 generations on1descendant
- K222849AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2…Steris · 2022 · 2 generations on0descendants
- K190027SteriStayToul Meditech AB · 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 | K160433 | V-PRO® 1 Plus and V-PRO® maX Low Temperature | STERIS Corporation | 2016 | — |
| −2 | K162413 | AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1 Plus Low… | STERIS Corporation | 2017 | 1 |
| −1 | K172319 | AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1 Plus Low… | STERIS Corporation | 2018 | 1 |
| 0 (this device) | K182568 | V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature… | STERIS Corporation | 2019 | — |
| +1 | K190917 | V-PRO 60 a Low Tempurature Strilization Systems, V-PRO s2 Low Temperature… | STERIS Corporation | 2019 | — |
| +2 | K222543 | AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System… | Steris | 2022 | — |
| +2 | K222849 | AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System… | Steris | 2022 | — |
| +1 | K190027 | SteriStay | Toul Meditech AB | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 2 | 0 |
| 2022 | 2 | 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 MLR? 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 MLR device
- #1 K250802 STERRAD® 100NX Sterilizer with ALLClear™…score 14.0 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K172319 | AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1 Plus Low Temperature…Summary page 8…Temperature Sterilization System (originally cleared under K140498 with additional material compatibility claims cleared under K162413 and most recently, K172319) A comparison between the proposed V-PRO s2 Low Temperature Sterilization System to the predicate device is summ… | 2018 |
What descends from it? (4)
2 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?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 1.1 years on median.
- 5 of the 15 ancestors have a recall of any class.
- Of its descendants, K190917 (STERIS Corporation, 2019) has gone furthest, with 2 descendants of its own.
How does its category compare?
All MLR devicesMLR Sterilizer, Chemical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · MLR
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MLR
216in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MLR
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MLR
46in 2025
MAUDE reports naming product code MLR, 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 | 2 | — | 5 | 272 |
| 2008 | 0 | — | 8 | 536 |
| 2009 | 1 | — | 2 | 433 |
| 2010 | 0 | — | 1 | 211 |
| 2011 | 6 | 214 | 2 | 34 |
| 2012 | 2 | — | 3 | 101 |
| 2013 | 1 | — | 9 | 541 |
| 2014 | 2 | — | 3 | 399 |
| 2015 | 1 | — | 0 | 412 |
| 2016 | 4 | 183 | 0 | 286 |
| 2017 | 2 | — | 1 | 279 |
| 2018 | 2 | — | 0 | 289 |
| 2019 | 4 | 90 | 0 | 222 |
| 2020 | 0 | — | 0 | 174 |
| 2021 | 2 | — | 0 | 202 |
| 2022 | 2 | — | 0 | 188 |
| 2023 | 5 | 222 | 0 | 140 |
| 2024 | 3 | 216 | 0 | 44 |
| 2025 | 1 | — | 0 | 46 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The V-PRO s2 Low Temperature Sterilization System using VAPROX® HC Sterilant is intended for use in the terminal sterilization of properly prepared (cleaned, rinsed and dried) medical devices in Healthcare Facilities. The pre-programmed sterilization cycles operate at low pressure and low temperature, suitable for processing medical devices without leaving toxic residues. Each Cycle can sterilize non-lumened instruments and instruments with…
Read the full statement (1,112 words)
The V-PRO s2 Low Temperature Sterilization System using VAPROX® HC Sterilant is intended for use in the terminal sterilization of properly prepared (cleaned, rinsed and dried) medical devices in Healthcare Facilities. The pre-programmed sterilization cycles operate at low pressure and low temperature, suitable for processing medical devices without leaving toxic residues.
Each Cycle can sterilize non-lumened instruments and instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors.
The V-PRO s2 Sterilizer Non Lumen Cycle can sterilize:‡
Non-lumened instruments including non-lumened general medical instruments, non-lumened rigid, semi-rigid and flexible endoscopes.
‡ The validation studies were conducted using a validation load consisting of one instrument tray for a total weight of 25 lbs (11.3 kg).
The V-PRO s2 Sterilizer Fast Cycle can sterilize:‡
Medical devices (including single, dual and triple channeled rigid and semi-rigid endoscopes) with the following configurations:
• Single or dual channeled devices with stainless steel lumens that are ≥ 0.77 mm (~1/32”) internal diameter (ID) and ≤ 410 mm (~16-9/64”) in length
• Triple channeled devices with stainless steel lumens that are either:
≥ 1.2 mm (~3/64”) ID and ≤ 275 mm (~10-53/64”) in length
≥ 1.8 mm (~5/64”) ID and ≤ 310 mm (~12-13/64”) in length
or
≥ 2.8 mm (~7/64”) ID and ≤ 317 mm (12-31/64”) in length
Non-lumened instruments including non-lumened general medical instruments, non-lumened rigid, semi-rigid and flexible endoscopes.
‡ Validation testing for all lumen sizes was conducted using a maximum of eight (8) lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing. Validation testing was conducted using a validation load consisting of one pouched instrument tray and two pouched devices outside of the tray with a total weight of 4.0 lbs (~1.8kg).
The V-PRO s2 Sterilizer Flexible Cycle can sterilize:@
One surgical flexible endoscope (such as those used in ENT, Urology and Surgical Care) or bronchoscope with light cord (if not integral to endoscope), mat, and additional load.
• The flexible endoscope may be a single or dual lumen device with lumens that are ≥ 1 mm (~3/64”) ID and ≤ 990 mm in length.
• Additional load, up to 11 lb (5 kg) can include stainless steel lumens with the following dimensions
• ≥ 2 mm (~5/64”) ID and ≤ 400 mm (~15 3/4”) in length
• ≥ 0.76 mm (~1/32”) ID and ≤ 233 mm (~9 11/64”) in length
• ≥ 1.0 mm (~3/64”) ID and ≤ 254 mm (~10”) in length
@ The validation studies were conducted using a validation load consisting of two instrument trays. One tray contained one flexible endoscope, with silicone mat, instrument organizers and light cord (if not integral to scope), and the second tray contained additional load and twelve (12) stainless steel lumens for a total load weight of 11 lbs (5 kg). Hospital loads should not exceed the maximum number of lumens validated by this testing.
The V-PRO s2 Sterilizer Lumen Cycle can sterilize: ^
Medical devices (including single, dual and triple channeled rigid and semi-rigid endoscopes) with the following configurations:
• Single or dual channeled devices with stainless steel lumens that are ≥ 0.77 mm (~1/32”) internal diameter (ID) and ≤ 410 mm (16-9/64”) in length
• Triple channeled devices with stainless steel lumens that are either:
≥ 1.2 mm (~3/64”) ID and ≤ 275 mm (~10-53/64”) in length
≥ 1.8 mm (~5/64”) ID and ≤ 310 mm (~12-13/64”) in length
or
≥ 2.8 mm (~7/64”) ID and ≤ 317 mm (12-31/64”) in length
^ Validation testing for all lumen sizes was conducted using a maximum of twelve (12) stainless steel lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing. The validation studies were performed using a validation load consisting of one instrument tray and two pouches for a total weight of 11 lbs (5.0 kg).
The V-PRO® 60 Low Temperature Sterilization System using VAPROX® HC Sterilant is intended for use in the terminal sterilization of properly prepared (cleaned, rinsed and dried) medical devices in Healthcare Facilities. The pre-programmed sterilization cycles operate at low pressure and low temperature, suitable for processing medical devices without leaving toxic residues.
Each Cycle can sterilize non-lumened instruments and instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors.
The V-PRO 60 Sterilizer Non Lumen Cycle can sterilize:‡
Non-lumened instruments including non-lumened general medical instruments, non-lumened rigid, semi-rigid and flexible endoscopes.
‡ The validation studies were conducted using a validation load consisting of one instrument tray for a total weight of 25 lbs (11.3 kg).
The V-PRO 60 Sterilizer Flexible Cycle can sterilize:@
One surgical flexible endoscope (such as those used in ENT, Urology and Surgical Care) or bronchoscope with light cord (if not integral to endoscope), mat, and additional load.
• The flexible endoscope may be a single or dual lumen device with lumens that are ≥ 1 mm (~3/64”) ID and ≤ 990 mm (38-63/64”) in length.
• Additional load, up to 11 lb (5 kg) can include stainless steel lumens with the following dimensions
• ≥ 2 mm (~5/64”) ID and ≤ 400 mm (~15 3/4”) in length
• ≥ 0.76 mm (~1/32”) ID and ≤ 233 mm (~9 11/64”) in length
• ≥ 1.0 mm (~3/64”) ID and ≤ 254 mm (~10”) in length
@ The validation studies were conducted using a validation load consisting of two instrument trays. One tray contained one flexible endoscope, with silicone mat, instrument organizers and light cord (if not integral to scope), and the second tray contained additional load and twelve (12) stainless steel lumens for a total load weight of 11 lbs (5 kg). Hospital loads should not exceed the maximum number of lumens validated by this testing.
The V-PRO 60 Sterilizer Lumen Cycle can sterilize: ^
Medical devices (including single, dual and triple channeled rigid and semi-rigid endoscopes) with the following configurations:
• Single or dual channeled devices with stainless steel lumens that are ≥ 0.77 mm (~1/32”) internal diameter (ID) and ≤ 410 mm (16-9/64”) in length
• Triple channeled devices with stainless steel lumens that are either:
≥ 1.2 mm (~3/64”) ID and ≤ 275 mm (~10-53/64”) in length
≥ 1.8 mm (~5/64”) ID and ≤ 310 mm (~12-13/64”) in length
or
≥ 2.8 mm (~7/64”) ID and ≤ 317 mm (12-31/64”) in length
^ Validation testing for all lumen sizes was conducted using a maximum of twelve (12) stainless steel lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing. The validation studies were performed using a validation load consisting of one instrument tray and two pouches for a total weight of 11 lbs (5.0 kg).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182568 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182568: V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182568
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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