# K190027: SteriStay

- Pathway: 510(k) (Traditional)
- Applicant: Toul Meditech AB
- Decided: May 10, 2019 after 123 days
- Product code: ORC (Air Filter Portable Apparatus)
- Device class: 2
- Regulation: 21 CFR 878.5070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K020875 (2003). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182568: V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System, STERIS Corporation (2019) Summary page 8.

## Indications for use
The V-PRO s2 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 and instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors. The V-PRO s2 Sterilizer 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 for a total weight of 25 lbs (11.3 kg). The V-PRO s2 Sterilizer Fast 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 ≥ 1.8 mm (~5/64”) ID x ≤ 542 mm (~21-5/16”) in length. • Triple channeled devices with stainless steel lumens that are either: ≥ 1.2 mm (~3/64”) ID and ≤ 275 mm (~10-53/64”) 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 Non-lumened instruments including non-lumened general medical instruments, non-lumened rigid, semi-rigid and flexible endoscopes. ‡ Validation testing for all lumen sizes was conducted using a maximum of eight (8) lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing. Validation testing was conducted using a validation load consisting of one pouched instrument tray and two pouched devices outside of the tray with a total weight of 4.0 lbs (~1.8kg). The V-PRO s2 Sterilizer 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), mat, and additional load. • The flexible endoscope may be a single or dual lumen device with lumens that are ≥ 1 mm ID and ≤ 990 mm in length • Additional load, up to 11 lb (5 kg) can include stainless steel lumens with the following dimensions ≥ 0.76 mm (~1/32”) ID and ≤ 233 mm (~9 11/64”) in length ≥ 1.0 mm (~3/64”) ID and ≤ 254 mm (~10”) in length ≥ 1.8 mm (~5/64”) ID and ≤ 542 mm (~21-5/16”) in length @ The validation studies were conducted using a validation load consisting of two instrument trays. One tray contained one flexible endoscope, with silicone mat, instrument organizers and light cord (if not integral to scope), and the second tray contained additional load and twelve (12) stainless steel lumens for a total load weight of 11 lbs (5 kg). Hospital loads should not exceed the maximum number of lumens validated by this testing. The V-PRO s2 Sterilizer 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”) ID and ≤ 410 mm (16-9/64”) in length ≥ 1.8 mm (~5/64) ID x ≤ 542 mm (~21-5/16") in length • Triple channeled devices with stainless steel lumens that are either: ≥ 1.2 mm (~3/64”) ID and ≤ 275 mm (~10-53/64”) 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) stainless steel 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). 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 and instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors. The V-PRO 60 Sterilizer 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 for a total weight of 25 lbs (11.3 kg). The V-PRO 60 Sterilizer 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), mat, and additional load. • The flexible endoscope may be a single or dual lumen device with lumens that are ≥ 1 mm (~3/64”) internal diameter (ID) and ≤ 990 mm (38-63/64”) in length • Additional load, up to 11 lb (5 kg) can include stainless steel lumens with the following dimensions ≥ 0.76 mm (~1/32”) ID and ≤ 233 mm (~9-11/64”) in length ≥ 1.0 mm (~3/64”) ID and ≤ 254 mm (~10”) in length ≥ 1.8mm (~5/64”) ID and ≤ 542 mm (~21-5/16”) in length @ The validation studies were conducted using a validation load consisting of two instrument trays. One tray contained one flexible endoscope, with silicone mat, instrument organizers and light cord (if not integral to scope), and the second tray contained additional load and twelve (12) stainless steel lumens for a total load weight of 11 lbs (5 kg). Hospital loads should not exceed the maximum number of lumens validated by this testing. The V-PRO 60 Sterilizer 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”) ID and ≤ 410 mm (16-9/64”) in length ≥ 1.8 mm (~5/64") ID x ≤ 542 mm (~21-5/16") length • Triple channeled devices with stainless steel lumens that are either: ≥ 1.2 mm (~3/64”) ID and ≤ 275 mm (~10-53/64”) 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) stainless steel 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/K190027
Methodology: https://510kreport.com/methodology