510(k) · Cleared
ClearedV-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 1 Plus Low Temperature Sterilization System, V-PRO 1 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 Apr 5, 2019 after a 73-day review. The FDA summary names no predicate by number. 5 later devices descend from it.
- Decided
- Apr 5, 2019
- Review
- 73 days
- Class
- Class II
- Product code
- MLR
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK190103 V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low…STERIS Corporation · 2019
- Descendant · cites it directly · 2 of its ownK222093 V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low…Steris · 2022
- Descendant · 2 generations on · 1 of its ownK223476 V-PRO maX 2 Low Temperature Sterilization SystemSTERIS Corporation · 2023
- Descendant · cites it directly · 1 of its ownK222543 AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature…Steris · 2022
- Descendant · 3 generations on · 0 of its ownK233065 V-PRO maX 2 Low Temperature Sterilization SystemSteris · 2023
- Descendant · 2 generations on · 0 of its ownK222849 AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature…Steris · 2022
Most influential descendants
Showing 5 of 5 · See all- K222093V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature…Steris · 2022 · cites it directly2descendants
- K223476V-PRO maX 2 Low Temperature Sterilization SystemSTERIS Corporation · 2023 · 2 generations on1descendant
- K222543AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2…Steris · 2022 · cites it directly1descendant
- K233065V-PRO maX 2 Low Temperature Sterilization SystemSteris · 2023 · 3 generations on0descendants
- K222849AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2…Steris · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K190103 | V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature… | STERIS Corporation | 2019 | — |
| +1 | K222093 | V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature… | Steris | 2022 | — |
| +2 | K223476 | V-PRO maX 2 Low Temperature Sterilization System | STERIS Corporation | 2023 | — |
| +1 | K222543 | AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System… | Steris | 2022 | — |
| +3 | K233065 | V-PRO maX 2 Low Temperature Sterilization System | Steris | 2023 | — |
| +2 | K222849 | AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System… | Steris | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 3 | 0 |
| 2023 | 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?
The FDA summary names no predicate by number.
What descends from it? (5)
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?
- Of its descendants, K222093 (Steris, 2022) 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 | — |
https://510kreport.com/device/K190103 · printed Nov 5, 2026
Cite this page
510(k) Report. “K190103: V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 1 Plus Low Temperature Sterilization System, V-PRO 1 Low Temperature Sterilization System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K190103
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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