# K172319: AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1 Plus Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System

- Pathway: 510(k) (Traditional)
- Applicant: STERIS Corporation
- Decided: Jan 18, 2018 after 170 days
- Product code: MLR (Sterilizer, Chemical)
- Device class: 2
- Regulation: 21 CFR 880.6860
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K020875 (2003). 14 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162413: AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1 Plus Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System, STERIS Corporation (2017) Summary page 8.

## Most influential descendants
- K182568: V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System (2019), 4 descendants of its own
- K190917: V-PRO 60 a Low Tempurature Strilization Systems, V-PRO s2 Low Temperature Sterilization Systems (2019), 2 descendants 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
- 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
- K190027: SteriStay (2019), 0 descendants of its own

## Recalls of this device
- Jul 26, 2018 · Class II · Z-2959-2018: There is the potential for a scenario where a punctured cup of sterilant expires while the system is powered down, upon power-up the unit will not detect the expired cup of sterilant; allowing for sub

## Indications for use
The V-PRO 1, V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems using VAPROX HC Sterilant are intended for use in the terminal sterilization of properly prepared (cleaned, rinsed and dried) medical devices in Healthcare Facilities. The preprogrammed sterilization cycles operate at low pressure and temperature, suitable for processing medical devices without leaving toxic residues. Each Cycle can sterilize non-lumened instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors. Only stainless steel or titanium diffusion-restricted spaces should be processed in the Non Lumen Cycle. The V-PRO 1 Plus and V-PRO maX Sterilizers’ Non Lumen Cycle can sterilize: ‡ Non-lumened instruments including non-lumened general medical instruments, non-lumened rigid, semi-rigid and flexible endoscopes. ‡ The validation studies were conducted using a validation load consisting of two instrument trays for a total weight of 50 lbs (22.7 kg). The V-PRO maX Sterilizer’s Flexible Cycle can sterilize: Single or dual lumen surgical flexible endoscopes (such as those used in ENT, Urology and Surgical Care) and bronchoscopes in either of the two configurations: 1. 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 that is • 1 mm internal diameter (ID) and ” 1050 mm in length • Or two lumens with: - One lumen that is • 1 mm ID and ” 990 mm 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. †† The flexible endoscope may contain either: • A single lumen that is • 1 mm ID and ” 1050 mm in length • Or two lumens with: - One lumen that is • 1 mm ID and ” 990 mm in length - And the other lumen is • 1 mm ID and ” 850 mm 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 weight of 24 lbs (11 kg). The V-PRO 1, V-PRO 1 Plus and V-PRO maX Sterilizers’ Lumen Cycle can sterilize: † Medical devices (including single, dual and triple channeled rigid and semi-rigid endoscopes) with the following configurations: • Single channeled devices with a stainless lumen that is • 0.77 mm ID and ” 500 mm in length • Dual channeled devices with stainless lumens that are • 0.77 mm ID and ” 527 mm in length • Triple channeled devices with stainless lumens that are either: • 1.2 mm ID and ” 275 mm in length • 1.8 mm ID and ” 310 mm in length or • 2.8 mm ID and ” 317 mm in length † Validation testing for all lumen sizes was conducted using a maximum of 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 (8.9 kg). The V-PRO 60 Low Temperature Sterilization System using VAPROX® HC Sterilant is intended for use in the terminal sterilization of properly prepared (cleaned, rinsed and dried) medical devices in Healthcare Facilities. The pre-programmed sterilization cycles operate at low pressure and low temperature, suitable for processing medical devices without leaving toxic residues. Each Cycle can sterilize non-lumened instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors. Only stainless steel or titanium diffusion restricted spaces should be processed in the Non Lumen Cycle. The V-PRO 60 Sterilizer’s Non Lumen Cycle can sterilize:‡ Non-lumened instruments including non-lumened general medical instruments, non-lumened rigid, semi-rigid and flexible endoscopes. ‡ The validation studies were conducted using a validation load consisting of one instrument tray and one pouch for a total weight of 12 lbs (5.4 kg). The V-PRO 60 Sterilizer’s Flexible Cycle can sterilize:@ One surgical flexible endoscope (such as those used in ENT, Urology and Surgical Care) or bronchoscope with light cord (if not integral to endoscope) and mat without additional load. The flexible endoscope may be a single or dual lumen device with lumens that are > 1 mm (~3/64”) ID and < 990 mm (38-63/64”) in length. @ The validation studies were conducted using a validation load consisting of one instrument tray containing one flexible endoscope, with silicone mat, instrument organizers and light cord (if not integral to scope). The V-PRO 60 Sterilizer’s Lumen Cycle can sterilize: ^ Medical devices (including single, dual and triple channeled rigid and semi-rigid endoscopes) with the following configurations: • Single or dual channeled devices with stainless steel lumens that are • 0.77 mm (~1/32”) internal diameter (ID) and ” 410 mm (16-9/64”) in length • Triple channeled devices with stainless steel lumens that are either: • 1.2 mm (~3/64”) ID and ” 275 mm (~10-55/64”) in length • 1.8 mm (~5/64”) ID and ” 310 mm (~12-13/64”) in length or • 2.8 mm (~7/64”) ID and ” 317 mm (12-31/64”) in length ^ Validation testing for all lumen sizes was conducted using a maximum of twelve (12) 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 one instrument tray and two pouches for a total weight of 11 lbs (5.0 kg).

Source page: https://510kreport.com/device/K172319
Methodology: https://510kreport.com/methodology