510(k) · Cleared
ClearedSteriStay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Toul Meditech AB · ORC Air Filter Portable Apparatus
Cleared on May 10, 2019 as substantially equivalent to K182568 (STERIS Corporation, 2019) after a 123-day review. Its family tree reaches back 11 generations to 2003.
- Decided
- May 10, 2019
- Review
- 123 days
- Class
- Class II
- Product code
- ORC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K020875 (2003). 16 ancestors in all. No later device cites it as a predicate yet.
- Root · 11 generations backK020875 TSO3 Ozone Sterilizer, Model 125LTechnologies of Sterilization With Oxone, Tso3, Inc. · 2003
- 7 generations between
- 3 generations backK162413 AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1…STERIS Corporation · 2017 · Recalled
- 2 generations backK172319 AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1…STERIS Corporation · 2018 · Recalled
- 1 generation backK182568 V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low…STERIS Corporation · 2019
- This deviceK190027 SteriStayToul Meditech AB · 2019
Show all 11 generations
- Root · 11 generations backK020875 TSO3 Ozone Sterilizer, Model 125LTechnologies of Sterilization With Oxone, Tso3, Inc. · 2003
- 10 generations backK051595 TSO3 Ozone Sterilizer, Model 125LTso3, Inc. · 2006
- 9 generations backK090636 TSO3 Ozone Sterilizer, Model 125LTso3, Inc. · 2009
- 8 generations backK102330 Amsco V-Pro Max Low Temperature Sterilization SystemSTERIS Corporation · 2011
- 7 generations backK112760 Amsco V-Pro Max Low Temperature Sterilization SystemSTERIS Corporation · 2011
- 6 generations backK120632 Amsco V-Pro 1 Low/Plus/Max Temperature Sterilization SystemSTERIS Corporation · 2012
- 5 generations backK131120 Amsco V-Pro 1 Low, V-Pro 1 Plus, V-Pro Max Low Temperature…STERIS Corporation · 2013
- 4 generations backK160433 V-PRO® 1 Plus and V-PRO® maX Low TemperatureSTERIS Corporation · 2016
- 3 generations backK162413 AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1…STERIS Corporation · 2017 · Recalled
- 2 generations backK172319 AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1…STERIS Corporation · 2018 · Recalled
- 1 generation backK182568 V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low…STERIS Corporation · 2019
- This deviceK190027 SteriStayToul Meditech AB · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K020875 | TSO3 Ozone Sterilizer, Model 125L | Technologies of Sterilization With Oxone, Tso3, Inc. | 2003 | — |
| −10 | K051595 | TSO3 Ozone Sterilizer, Model 125L | Tso3, Inc. | 2006 | — |
| −9 | K090636 | TSO3 Ozone Sterilizer, Model 125L | Tso3, Inc. | 2009 | — |
| −8 | K102330 | Amsco V-Pro Max Low Temperature Sterilization System | STERIS Corporation | 2011 | — |
| −7 | K112760 | Amsco V-Pro Max Low Temperature Sterilization System | STERIS Corporation | 2011 | — |
| −6 | K120632 | Amsco V-Pro 1 Low/Plus/Max Temperature Sterilization System | STERIS Corporation | 2012 | — |
| −5 | K131120 | Amsco V-Pro 1 Low, V-Pro 1 Plus, V-Pro Max Low Temperature Sterilization System | STERIS Corporation | 2013 | — |
| −4 | K160433 | V-PRO® 1 Plus and V-PRO® maX Low Temperature | STERIS Corporation | 2016 | — |
| −3 | K162413 | AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1 Plus Low… | STERIS Corporation | 2017 | 1 |
| −2 | K172319 | AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1 Plus Low… | STERIS Corporation | 2018 | 1 |
| −1 | K182568 | V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature… | STERIS Corporation | 2019 | — |
| 0 (this device) | K190027 | SteriStay | Toul Meditech AB | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 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 ORC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K182568 | V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization…Summary page 8…erilizer, Ethylene Oxide Gas Classification Number: 21 CFR 880.6860 Product Code: MLR 2. Predicate Devices Primary Predicate: K182568 V-PRO® s2 and V-PRO® 60 Low Temperature Sterilization Systems Reference Device: K… | 2019 |
| † | K190103 | V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 16 years and passes through 4 companies; a new generation was cleared every 11 months on median.
- 5 of the 16 ancestors have a recall of any class.
- 1 other device also cites its predicate K182568.
How does its category compare?
All ORC devicesORC Air Filter Portable Apparatus: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · ORC
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · ORC
Too few ORC 510(k)s in any year since 2007 to give a median.
Recalls per year · ORC
No recall names ORC since 2007.
Adverse event reports per year · ORC
No MAUDE report names ORC since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (1,134 words)
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).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190027 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190027: SteriStay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190027
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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