510(k) · Cleared
Recalled · 2011VHP 136 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 Oct 4, 2007 after a 423-day review. The FDA summary names its predicate without a number. 31 later devices descend from it. It has been recalled once.
- Decided
- Oct 4, 2007
- Review
- 423 days
- Class
- Class II
- Product code
- MLR
- Recalls
- 1
- Predicates
- 0
31 later devices descend from it, 8 citing it directly.
- This deviceK062297 VHP 136 Low Temperature Sterilization SystemSTERIS Corporation · 2007
- Descendant · cites it directly · 27 of its ownK083097 Amsco V-Pro 1 Low Temperature Sterilization SystemSTERIS Corporation · 2009 · Recalled
- Descendant · cites it directly · 21 of its ownK102330 Amsco V-Pro Max Low Temperature Sterilization SystemSTERIS Corporation · 2011
- Descendant · 2 generations on · 18 of its ownK112760 Amsco V-Pro Max Low Temperature Sterilization SystemSTERIS Corporation · 2011
- Descendant · cites it directly · 18 of its ownK111810 Amsco V-Pro 1 and V-Pro 1 Plus Low Temperature Sterilization UnitsSTERIS Corporation · 2011
- Descendant · cites it directly · 18 of its ownK102394 Amsco V-Pro 1 Low Temperature Sterilization System; Amsco V-Pro 1…STERIS Corporation · 2011
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 31 · See all- K083097Amsco V-Pro 1 Low Temperature Sterilization SystemSTERIS Corporation · 2009 · cites it directly27descendants
- K102330Amsco V-Pro Max Low Temperature Sterilization SystemSTERIS Corporation · 2011 · cites it directly21descendants
- K112760Amsco V-Pro Max Low Temperature Sterilization SystemSTERIS Corporation · 2011 · 2 generations on18descendants
- K111810Amsco V-Pro 1 and V-Pro 1 Plus Low Temperature Sterilization UnitsSTERIS Corporation · 2011 · cites it directly18descendants
- K102394Amsco V-Pro 1 Low Temperature Sterilization System; Amsco V-Pro 1 Plus Low Temperature…STERIS Corporation · 2011 · cites it directly18descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K062297 | VHP 136 Low Temperature Sterilization System | STERIS Corporation | 2007 | — |
| +1 | K083097 | Amsco V-Pro 1 Low Temperature Sterilization System | STERIS Corporation | 2009 | 1 |
| +1 | K102330 | Amsco V-Pro Max Low Temperature Sterilization System | STERIS Corporation | 2011 | — |
| +2 | K112760 | Amsco V-Pro Max Low Temperature Sterilization System | STERIS Corporation | 2011 | — |
| +1 | K111810 | Amsco V-Pro 1 and V-Pro 1 Plus Low Temperature Sterilization Units | STERIS Corporation | 2011 | — |
| +1 | K102394 | Amsco V-Pro 1 Low Temperature Sterilization System; Amsco V-Pro 1 Plus Low… | STERIS Corporation | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 5 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 4 | 0 |
| 2019 | 5 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 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? (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 |
|---|---|---|---|
| * | — | Sterrad 100S Sterilization System Named without a submission number |
What descends from it? (31)
See all 318 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083097 | Amsco V-Pro 1 Low Temperature Sterilization System | 2009 | 27 |
| K102330 | Amsco V-Pro Max Low Temperature Sterilization System | 2011 | 21 |
| K111810 | Amsco V-Pro 1 and V-Pro 1 Plus Low Temperature Sterilization Units | 2011 | 18 |
| K102394 | Amsco V-Pro 1 Low Temperature Sterilization System; Amsco V-Pro 1 Plus Low Temperature… | 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 1, 2011 | Not classified | Z-3041-2011 | Other | STERIS learned that Amsco V-PRO 1 and V-PRO 1 Plus Low Temperature Sterilization Systems users may experience premature wear of the vacuum pump and filtering assembly components. Users may also experience incomplete aeration of the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K083097 (STERIS Corporation, 2009) has gone furthest, with 27 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. 2007, 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 1 Low Temperature Sterilization System and Vaprox® HC Hydrogen Peroxide Sterilant (59%) are intended for use in terminal sterilization of cleaned, rinsed, and dried, reusable metal and nonmetal medical devices used in healthcare facilities. The V-PRO 1 Low Temperature Sterilization System can sterilize*: · Instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors. * Medical devices with a single stainless…
Read the full statement (177 words)
The V-PRO 1 Low Temperature Sterilization System and Vaprox® HC Hydrogen Peroxide Sterilant (59%) are intended for use in terminal sterilization of cleaned, rinsed, and dried, reusable metal and nonmetal medical devices used in healthcare facilities.
The V-PRO 1 Low Temperature Sterilization System can sterilize*:
· Instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors.
* Medical devices 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 inside 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 400 mm or shorter
* The 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062297 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062297: VHP 136 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/K062297
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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