510(k) · Cleared
ClearedAmsco V-Pro Max 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 Aug 12, 2011 as substantially equivalent to K062297 (STERIS Corporation, 2007) and 2 other predicates after a 360-day review. Its family tree reaches back 3 generations to 2003. 21 later devices descend from it.
- Decided
- Aug 12, 2011
- Review
- 360 days
- Class
- Class II
- Product code
- MLR
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K020875 (2003). 5 ancestors in all. 21 later devices descend from it, 5 citing it directly.
- Root · 3 generations backK020875 TSO3 Ozone Sterilizer, Model 125LTechnologies of Sterilization With Oxone, Tso3, Inc. · 2003
- 2 generations backK051595 TSO3 Ozone Sterilizer, Model 125LTso3, Inc. · 2006
- 1 generation backK090636 TSO3 Ozone Sterilizer, Model 125LTso3, Inc. · 2009
- This deviceK102330 Amsco V-Pro Max Low Temperature Sterilization SystemSTERIS Corporation · 2011
- Descendant · cites it directly · 18 of its ownK112760 Amsco V-Pro Max Low Temperature Sterilization SystemSTERIS Corporation · 2011
- Descendant · cites it directly · 17 of its ownK120632 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
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K112760Amsco V-Pro Max Low Temperature Sterilization SystemSTERIS Corporation · 2011 · cites it directly18descendants
- K120632Amsco V-Pro 1 Low/Plus/Max Temperature Sterilization SystemSTERIS Corporation · 2012 · cites it directly17descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K020875 | TSO3 Ozone Sterilizer, Model 125L | Technologies of Sterilization With Oxone, Tso3, Inc. | 2003 | — |
| −2 | K051595 | TSO3 Ozone Sterilizer, Model 125L | Tso3, Inc. | 2006 | — |
| −1 | K090636 | TSO3 Ozone Sterilizer, Model 125L | Tso3, Inc. | 2009 | — |
| 0 (this device) | 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 | — |
| +1 | 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 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 4 | 0 |
| 2019 | 4 | 0 |
| 2022 | 2 | 0 |
| 2024 | 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 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? (4)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K062297 | VHP 136 Low Temperature Sterilization SystemSummary page 2…ine currently consists of the Amsco V-PRO 1 and Amsco V-PRO 1 Plus Sterilizers. The V-PRO MAX Sterilizer has three pre-programmed cycles: the Lumen Cycle (K062297), the Non Lumen Cycle (K083097) and the Flexible Cycle (subject of this submission). The V-PRO MAX Low Temperature Sterili… | 2007 |
| Kept off the family tree | K080897 | FDA’s K080897 is Venturi Negative Pressure Wound Therapy System Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2008 |
| * | K042116 | Sterrad NX SterilizerSummary page 2…sco V-PRTM ILwTmeaueSeiiainSse K627 Amsco V-PROT 1 l Low Temperature Sterilization System (K0897) STERRAD® NX Sterilizer (K042 116) TS03 STERIIZONE® 125L Sterilizer (K090636) 3. Description of Device The Amsco V-PRO MAX Low Temperature Ste… | 2005 |
| * | K090636 | TSO3 Ozone Sterilizer, Model 125LSummary page 2…K627 Amsco V-PROT 1 l Low Temperature Sterilization System (K0897) STERRAD® NX Sterilizer (K042 116) TS03 STERIIZONE® 125L Sterilizer (K090636) 3. Description of Device The Amsco V-PRO MAX Low Temperature Sterilization System is a new sterilizer model… | 2009 |
What descends from it? (21)
See all 215 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112760 | Amsco V-Pro Max Low Temperature Sterilization System | 2011 | 18 |
| K120632 | Amsco V-Pro 1 Low/Plus/Max Temperature Sterilization System | 2012 | 17 |
| K131120 | Amsco V-Pro 1 Low, V-Pro 1 Plus, V-Pro Max Low Temperature Sterilization System | 2013 | 16 |
| K231893 | LOWTEM Crystal 120 | 2024 | 0 |
| K112813 | Amsco V-Pro | 2011 | 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 8 years and passes through 3 companies; a new generation was cleared every 2.9 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K112760 (STERIS Corporation, 2011) has gone furthest, with 18 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. 2011, 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-PROTM MAX Low Temperature Sterilization System, with VAPROXTM 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 three pre-programmed sterilization cycles (Lumen Cycle, Non Lumen Cycle, and Flexible Cycle) operate at low pressure and low temperature and are thus suitable for…
Read the full statement (592 words)
The Amsco® V-PROTM MAX Low Temperature Sterilization System, with VAPROXTM 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 three 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 Amsco V-PRO MAX Low Temperature Sterilization System's Lumen Cycle, cleared under K062297, can sterilize:
*Instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors
*Medical devices, including rigid endoscopes, with a single stainless steel lumen with:
o an inside diameter of 1 mm or larger and a length of 125 mm or shorter
o an insider diameter of 2 mm or larger and a length of 250 mm or shorter
o an inside diameter of 3 mm, or larger and a length of 4o0 mm or shorter
aThe validation testing for all lumen sizes was 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 MAX Low Temperature Sterilization System's Non Lumen Cycle, cleared under K083097, can sterilize:b
Non-lumened instruments including non-lumened rigid endoscopes and non-lumened instruments with stainless steel diffusion-restricted areas such as the hinged portion of forceps or scissors.
b 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, the subject of this submission, 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:
I. Two flexible endoscopes with a light cord (if not integral to endoscope) and mat with no additional load.
The flexible endoscopes may contain either:
a single lumen with an inside diameter of 1 mm or larger and a length of 1050 mm or shorter
or two lumens with:
* one lumen having an inside diameter of I mm or larger and a length of 998 mm or shorter
* and the other lumen having an inside diameter of I mm or larger and a length of 850 mm or shorter
CThe 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 forceps or scissors.
The flexible endoscope can contain either:
*a single lumen with an inside diameter of 1 mm or larger and a length of 1050 mm or shorter
*or two lumens with:
* one lumen having an inside diameter of 1 mm or larger and a length of 998 mum or shorter
* and the other lumen having an inside diameter of 1 mm or larger and a length of 850 mm or shorter
d 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K102330 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102330: Amsco V-Pro Max 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/K102330
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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