# 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

- Pathway: 510(k) (Special)
- Applicant: STERIS Corporation
- Decided: Apr 5, 2019 after 73 days
- Product code: MLR (Sterilizer, Chemical)
- Device class: 2
- Regulation: 21 CFR 880.6860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K222093: V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System (2022), 2 descendants of its own
- K223476: V-PRO maX 2 Low Temperature Sterilization System (2023), 1 descendant of its own
- K222543: AMSCO 600 Steam Sterilizer,  V-PRO maX 2 Low Temperature Sterilization System,  V-PRO s2 Low Temperature Sterilization System, RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP and 7053HP Single Chamber Washer Disinfector (2022), 1 descendant of its own
- K233065: V-PRO maX 2 Low Temperature Sterilization System (2023), 0 descendants of its own
- K222849: AMSCO 600 Steam Sterilizer,  V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System,  RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP and 7053HP Single Chamber Washer Disinfector (2022), 0 descendants of its own

Source page: https://510kreport.com/device/K190103
Methodology: https://510kreport.com/methodology