510(k) · Cleared
ClearedAmsco V-Pro 1 Low/Plus/Max 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 Jun 26, 2012 as substantially equivalent to K062297 (STERIS Corporation, 2007) and 5 other predicates after a 117-day review. Its family tree reaches back 5 generations to 2003. 17 later devices descend from it.
- Decided
- Jun 26, 2012
- Review
- 117 days
- Class
- Class II
- Product code
- MLR
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 5 generations to K020875 (2003). 10 ancestors in all. 17 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK020875 TSO3 Ozone Sterilizer, Model 125LTechnologies of Sterilization With Oxone, Tso3, Inc. · 2003
- 4 generations backK051595 TSO3 Ozone Sterilizer, Model 125LTso3, Inc. · 2006
- 3 generations backK090636 TSO3 Ozone Sterilizer, Model 125LTso3, Inc. · 2009
- 2 generations backK102330 Amsco V-Pro Max Low Temperature Sterilization SystemSTERIS Corporation · 2011
- 1 generation backK112760 Amsco V-Pro Max Low Temperature Sterilization SystemSTERIS Corporation · 2011
- This deviceK120632 Amsco V-Pro 1 Low/Plus/Max Temperature Sterilization SystemSTERIS Corporation · 2012
- Descendant · cites it directly · 16 of its ownK131120 Amsco V-Pro 1 Low, V-Pro 1 Plus, V-Pro Max Low Temperature…STERIS Corporation · 2013
- Descendant · 2 generations on · 8 of its ownK160433 V-PRO® 1 Plus and V-PRO® maX Low TemperatureSTERIS Corporation · 2016
- Descendant · 3 generations on · 7 of its ownK162413 AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1…STERIS Corporation · 2017 · Recalled
- Descendant · 4 generations on · 5 of its ownK172319 AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1…STERIS Corporation · 2018 · Recalled
- Descendant · 2 generations on · 5 of its ownK141163 Sterizone SterilizerTso3, Inc. · 2014
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K131120Amsco V-Pro 1 Low, V-Pro 1 Plus, V-Pro Max Low Temperature Sterilization SystemSTERIS Corporation · 2013 · cites it directly16descendants
- K160433V-PRO® 1 Plus and V-PRO® maX Low TemperatureSTERIS Corporation · 2016 · 2 generations on8descendants
- K162413AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1 Plus Low Temperature…STERIS Corporation · 2017 · 3 generations on7descendants
- K172319AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1 Plus Low Temperature…STERIS Corporation · 2018 · 4 generations on5descendants
- K141163Sterizone SterilizerTso3, Inc. · 2014 · 2 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K020875 | TSO3 Ozone Sterilizer, Model 125L | Technologies of Sterilization With Oxone, Tso3, Inc. | 2003 | — |
| −4 | K051595 | TSO3 Ozone Sterilizer, Model 125L | Tso3, Inc. | 2006 | — |
| −3 | K090636 | TSO3 Ozone Sterilizer, Model 125L | Tso3, Inc. | 2009 | — |
| −2 | K102330 | Amsco V-Pro Max Low Temperature Sterilization System | STERIS Corporation | 2011 | — |
| −1 | K112760 | Amsco V-Pro Max Low Temperature Sterilization System | STERIS Corporation | 2011 | — |
| 0 (this device) | 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 | — |
| +2 | K160433 | V-PRO® 1 Plus and V-PRO® maX Low Temperature | STERIS Corporation | 2016 | — |
| +3 | K162413 | AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1 Plus Low… | STERIS Corporation | 2017 | 1 |
| +4 | K172319 | AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1 Plus Low… | STERIS Corporation | 2018 | 1 |
| +2 | K141163 | Sterizone Sterilizer | Tso3, Inc. | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 4 | 0 |
| 2019 | 4 | 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? (6)
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 |
|---|---|---|---|
| * | K062297 | VHP 136 Low Temperature Sterilization SystemSummary page 2…21 CFR 880.6860 Product Code MLR 2. Predicate Devices Amnsco® V-PRO® I Low Temperature Sterilization System (K062297, K 102394, and K! 11810) Amnsco®D V-PRO elI Plus Low Temperature Sterilization System (K083097, K102394. and… | 2007 |
| * | K102394 | Amsco V-Pro 1 Low Temperature Sterilization System; Amsco V-Pro 1 Plus Low Temperature…Summary page 2…CFR 880.6860 Product Code MLR 2. Predicate Devices Amnsco® V-PRO® I Low Temperature Sterilization System (K062297, K 102394, and K! 11810) Amnsco®D V-PRO elI Plus Low Temperature Sterilization System (K083097, K102394. and KI 11810)… | 2011 |
| * | K111810 | Amsco V-Pro 1 and V-Pro 1 Plus Low Temperature Sterilization Units | 2011 |
| * | K083097 | Amsco V-Pro 1 Low Temperature Sterilization SystemSummary page 2…Amnsco® V-PRO® I Low Temperature Sterilization System (K062297, K 102394, and K! 11810) Amnsco®D V-PRO elI Plus Low Temperature Sterilization System (K083097, K102394. and KI 11810) Amsco® V-PRO® maX Low Temperature Sterilization System (K102330, KI 12760) 3. Descrip… | 2009 |
| * | K102330 | Amsco V-Pro Max Low Temperature Sterilization SystemSummary page 2…Amnsco®D V-PRO elI Plus Low Temperature Sterilization System (K083097, K102394. and KI 11810) Amsco® V-PRO® maX Low Temperature Sterilization System (K102330, KI 12760) 3. Description of Device The Amsco V-PRO 1, V-PRO I Plus and V-PRO maX Low Temperature Sterilizat… | 2011 |
| * | K112760 | Amsco V-Pro Max Low Temperature Sterilization System | 2011 |
What descends from it? (17)
See all 171 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131120 | Amsco V-Pro 1 Low, V-Pro 1 Plus, V-Pro Max Low Temperature Sterilization System | 2013 | 16 |
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 9 years and passes through 3 companies; a new generation was cleared every 1.7 years on median.
- 3 of the 10 ancestors have a recall of any class.
- Of its descendants, K131120 (STERIS Corporation, 2013) has gone furthest, with 16 descendants of its own.
- 7 other devices also cite its predicate K062297.
How does its category compare?
All MLR devicesMLR Sterilizer, Chemical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 Amsco V-PRO 1, V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems, with VAPROX1 HG Sterilant, are vaporized hydrogen peroxide sterilizers 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…
Read the full statement (608 words)
The Amsco V-PRO 1, V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems, with VAPROX1 HG Sterilant, are vaporized hydrogen peroxide sterilizers 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 hieat and moisture.
The Amsco V-PRO 1, V-PRO I Plus and V-PRO maX Low Temperature Sterilization Systems' Lumen Cycle, the subject of this submission, can sterilize:
* Lumened and non-lumened instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors
* Medical devices, including single, dual and triple channeled rigid and semi-rigid endoscopes, with the following configurations:
* single channeled devices with a stainless lumnen that is > 0.77 rm internal diameter (ID) and 500 mm in length
* dual channeled devices with stainless steel lumens that are > 0.77 mm ID and < 527 mm in length
* triple channeled devices with stainless steel lumens that are either > 1.2mm ID and 310mm in length or > 2.8 mm ID and 317 mm in length
The validation studies were conducted using a maximum of twenty (20) 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 two instrument trays and two pouches for a total weight of 19.65 lbs.
The Amsco V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems' Non Lumen Cycle, cleared under K083097, K102394, and KI 11810, can sterilize:
Non-lumened instruments including non-lumened rigid, semi-rigid and flexible endoscopes and non-lumened instruments with stainless steel diffusion-restricted areas such as the hinged portion of forceps or scissors.
The validation studies were conducted using a validation load consisting of two instrument trays and two pouches for a total weight of 19.65 lbs.
The Amsco V-PRO maX Low Temperature Sterilization System's Flexible Cycle, cleared under KI102330 and Ki 12760, can sterilize single or dual lumen surgical flexible endoscopes (such as those used in ENT, Urology and Surgical Care) and bronchoscopes in either of two load configurations:
1. Two flexible ehdoscopes with a light cord (if not integral to endoscope) and mat with no additional load.
The flexible endoscopes may contain either:
* a single lumen that is > I mm ID and < 1050 mm in length
* or two lumens with:
* one lumen that is > I mm ID and < 998 imm in length
* and the other lumen that is > 1 mm ID and < 850 mm in length
The validation studies were conducted with two flexible endoscopes, each packaged into a tray with silicone mat and light cord (if not integral to endoscope).
2. One flexible endoscope with a light cord (if not integral to endoscope) and mat and additional non-lumened instruments including instruments with diffusion-restricted areas such as the hinged portion of f6rceps or scissors.
The flexible endoscope can contain either:
* a single lumen that is > 1 mmr ID and < 1050mmn in length
* or two lumens with:
* one lumen that is.> 1 mm ID and < 998 mm, in length
* and the other lumen that is > 1 mm and < 850 mmn in length
The validation studies were conducted with a flexible endoscope in a tray with silicone mat and light cord (if not integral to endoscope). Also included in the load were an additional instrument tray and one pouch for a total load weight of 24.0 lbs.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120632 · printed Nov 4, 2026
Cite this page
510(k) Report. “K120632: Amsco V-Pro 1 Low/Plus/Max Temperature Sterilization System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120632
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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