510(k) · Cleared
ClearedV-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 Jul 24, 2014 as substantially equivalent to K131120 (STERIS Corporation, 2013) after a 147-day review. Its family tree reaches back 7 generations to 2003.
- Decided
- Jul 24, 2014
- Review
- 147 days
- Class
- Class II
- Product code
- MLR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K020875 (2003). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK020875 TSO3 Ozone Sterilizer, Model 125LTechnologies of Sterilization With Oxone, Tso3, Inc. · 2003
- 6 generations backK051595 TSO3 Ozone Sterilizer, Model 125LTso3, Inc. · 2006
- 5 generations backK090636 TSO3 Ozone Sterilizer, Model 125LTso3, Inc. · 2009
- 4 generations backK102330 Amsco V-Pro Max Low Temperature Sterilization SystemSTERIS Corporation · 2011
- 3 generations backK112760 Amsco V-Pro Max Low Temperature Sterilization SystemSTERIS Corporation · 2011
- 2 generations backK120632 Amsco V-Pro 1 Low/Plus/Max Temperature Sterilization SystemSTERIS Corporation · 2012
- 1 generation backK131120 Amsco V-Pro 1 Low, V-Pro 1 Plus, V-Pro Max Low Temperature…STERIS Corporation · 2013
- This deviceK140498 V-Pro 60 Low Temperature Sterilization SystemSTERIS Corporation · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K020875 | TSO3 Ozone Sterilizer, Model 125L | Technologies of Sterilization With Oxone, Tso3, Inc. | 2003 | — |
| −6 | K051595 | TSO3 Ozone Sterilizer, Model 125L | Tso3, Inc. | 2006 | — |
| −5 | K090636 | TSO3 Ozone Sterilizer, Model 125L | Tso3, Inc. | 2009 | — |
| −4 | 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 | — |
| −2 | K120632 | Amsco V-Pro 1 Low/Plus/Max Temperature Sterilization System | STERIS Corporation | 2012 | — |
| −1 | K131120 | Amsco V-Pro 1 Low, V-Pro 1 Plus, V-Pro Max Low Temperature Sterilization System | STERIS Corporation | 2013 | — |
| 0 (this device) | K140498 | V-Pro 60 Low Temperature Sterilization System | STERIS Corporation | 2014 | — |
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 |
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 |
|---|---|---|---|
| * | K131120 | Amsco V-Pro 1 Low, V-Pro 1 Plus, V-Pro Max Low Temperature Sterilization SystemSummary page 2…Product Code MLR Device Class: Class 11 2. Predicate Devices Amsco V-PRO maX Low Temperature Stetilization System (K131 120). Please note that the predicate device was originally cleared under K102330. A comparison between the proposed… | 2013 |
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 11 years and passes through 3 companies; a new generation was cleared every 1.1 years on median.
- 3 of the 12 ancestors have a recall of any class.
- 2 other devices also cite its predicate K131120.
How does its category compare?
All MLR devicesMLR Sterilizer, Chemical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 60 Low Temperature Sterilization System, with VAPROX® HC Sterilant, is a vaporized hydrogen peroxide sterilizer intended for use in the terminal sterilization of cleaned, rinsed and dried reusable metal and nonmetal medical devices used in Healthcare facilities. The pre-programmed sterilization cycles (Lumen Cycle, Non Lumen Cycle, and Flexible Cycle) operate at low pressure and low temperature and are thus suitable for processing medical…
Read the full statement (398 words)
The V-PRO 60 Low Temperature Sterilization System, with VAPROX® HC Sterilant, is a vaporized hydrogen peroxide sterilizer intended for use in the terminal sterilization of cleaned, rinsed and dried reusable metal and nonmetal medical devices used in Healthcare facilities. The pre-programmed sterilization cycles (Lumen Cycle, Non Lumen Cycle, and Flexible Cycle) operate at low pressure and low temperature and are thus suitable for processing medical devices sensitive to heat and moisture.
The V-PRO 60 Sterilizer's Lumen Cycle can sterilize:
Instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors
Non-lumened devices including non-lumened rigid and semi-rigid endoscopes
Medical devices, including single, dual and triple channeled rigid and semi-rigid endoscopes, with the following configurations:
a. Single or dual lumen devices with stainless steel lumens that are 0.77 mm (-1/32") internal diameter (ID) and 410 mm (16-9/64") in length
b. Triple lumen devices with stainless steel lumens that are 1.2 mm (-3/64") ID and 275 mm (-10-55/64") 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
The validation studies for all lumen configurations were conducted using a maximum of twelve (12) 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 with instrument organizers and mat and two pouches for a total weight of 11 lbs (5.0 kg).
The V-PRO 60 Sterilizer's Non Lumen Cycle can sterilize:
Non-lumened devices including non-lumened rigid, semi-rigid and flexible endoscopes and non-lumened devices with stainless steel or titanium diffusion-restricted spaces such as the hinged portion of forceps and scissors.
The validation studies were performed using a validation load consisting of one instrument tray with instrument organizers and mat and one pouch for a total weight of 12 lbs (5.4 kg).
The V-PRO 60 Sterilizer's Flexible Cycle can sterilize:
One flexible surgical endoscope or bronchoscope with a light cord (if not integral to endoscope) and mat without any 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.
The validation studies were conducted with one flexible endoscope, packaged into a tray with silicone mat, instrument organizers and light cord (if not integral to scope) and no additional load.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140498 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140498: 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/K140498
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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