510(k) Report

510(k) · Cleared

Cleared

V-PRO 60 a Low Tempurature Strilization Systems, V-PRO s2 Low Temperature Sterilization Systems

K190917510(k) SpecialCleared May 9, 201930-day reviewClass II21 CFR 880.6860

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

STERIS Corporation · MLR Sterilizer, Chemical

Cleared on May 9, 2019 as substantially equivalent to K182568 (STERIS Corporation, 2019) after a 30-day review. Its family tree reaches back 11 generations to 2003. 2 later devices descend from it.

Decided
May 9, 2019
Review
30 days
Class
Class II
Product code
MLR
Recalls
None
Predicates
1

Its longest line of descent runs back 11 generations to K020875 (2003). 16 ancestors in all. 2 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2011: 2 other ancestors2009: 1 other ancestor2007: 1 other ancestor2005: 1 other ancestor2022: 2 descendants clearedReference device: 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 · STERIS Corporation · 2019K020875 · TSO3 Ozone Sterilizer, Model 125L · Technologies of Sterilization With Oxone, Tso3, Inc. · 2003K051595 · TSO3 Ozone Sterilizer, Model 125L · Tso3, Inc. · 2006K090636 · TSO3 Ozone Sterilizer, Model 125L · Tso3, Inc. · 2009K102330 · Amsco V-Pro Max Low Temperature Sterilization System · STERIS Corporation · 2011K112760 · Amsco V-Pro Max Low Temperature Sterilization System · STERIS Corporation · 2011K120632 · Amsco V-Pro 1 Low/Plus/Max Temperature Sterilization System · STERIS Corporation · 2012K131120 · Amsco V-Pro 1 Low, V-Pro 1 Plus, V-Pro Max Low Temperature Sterilization System · STERIS Corporation · 2013K160433 · V-PRO® 1 Plus and V-PRO® maX Low Temperature · STERIS Corporation · 2016K162413 · 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 · recalledK172319 · 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 · 2018 · recalledK182568 · V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System · STERIS Corporation · 2019200020052010201520202025
Other ancestors, by generationDescendants, by generation 6 generations back: 4 other ancestors7 generations back: 1 other ancestor 1 generation forward: 2 descendants K182568 · V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System · STERIS Corporation · 2019K172319 · 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 · 2018 · recalledK162413 · 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 · recalledK160433 · V-PRO® 1 Plus and V-PRO® maX Low Temperature · STERIS Corporation · 2016K131120 · Amsco V-Pro 1 Low, V-Pro 1 Plus, V-Pro Max Low Temperature Sterilization System · STERIS Corporation · 2013K120632 · Amsco V-Pro 1 Low/Plus/Max Temperature Sterilization System · STERIS Corporation · 2012K112760 · Amsco V-Pro Max Low Temperature Sterilization System · STERIS Corporation · 2011K102330 · Amsco V-Pro Max Low Temperature Sterilization System · STERIS Corporation · 2011K090636 · TSO3 Ozone Sterilizer, Model 125L · Tso3, Inc. · 2009K051595 · TSO3 Ozone Sterilizer, Model 125L · Tso3, Inc. · 2006K020875 · TSO3 Ozone Sterilizer, Model 125L · Technologies of Sterilization With Oxone, Tso3, Inc. · 2003−10−50
  1. Root · 11 generations backK020875 TSO3 Ozone Sterilizer, Model 125LTechnologies of Sterilization With Oxone, Tso3, Inc. · 2003
  2. 7 generations between
  3. 3 generations backK162413 AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1…STERIS Corporation · 2017 · Recalled
  4. 2 generations backK172319 AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1…STERIS Corporation · 2018 · Recalled
  5. 1 generation backK182568 V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low…STERIS Corporation · 2019
  6. This deviceK190917 V-PRO 60 a Low Tempurature Strilization Systems, V-PRO s2 Low…STERIS Corporation · 2019
  7. Descendant · cites it directly · 1 of its ownK222543 AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature…Steris · 2022
  8. Descendant · cites it directly · 0 of its ownK222849 AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature…Steris · 2022
Show all 11 generations
  1. Root · 11 generations backK020875 TSO3 Ozone Sterilizer, Model 125LTechnologies of Sterilization With Oxone, Tso3, Inc. · 2003
  2. 10 generations backK051595 TSO3 Ozone Sterilizer, Model 125LTso3, Inc. · 2006
  3. 9 generations backK090636 TSO3 Ozone Sterilizer, Model 125LTso3, Inc. · 2009
  4. 8 generations backK102330 Amsco V-Pro Max Low Temperature Sterilization SystemSTERIS Corporation · 2011
  5. 7 generations backK112760 Amsco V-Pro Max Low Temperature Sterilization SystemSTERIS Corporation · 2011
  6. 6 generations backK120632 Amsco V-Pro 1 Low/Plus/Max Temperature Sterilization SystemSTERIS Corporation · 2012
  7. 5 generations backK131120 Amsco V-Pro 1 Low, V-Pro 1 Plus, V-Pro Max Low Temperature…STERIS Corporation · 2013
  8. 4 generations backK160433 V-PRO® 1 Plus and V-PRO® maX Low TemperatureSTERIS Corporation · 2016
  9. 3 generations backK162413 AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1…STERIS Corporation · 2017 · Recalled
  10. 2 generations backK172319 AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1…STERIS Corporation · 2018 · Recalled
  11. 1 generation backK182568 V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low…STERIS Corporation · 2019
  12. This deviceK190917 V-PRO 60 a Low Tempurature Strilization Systems, V-PRO s2 Low…STERIS Corporation · 2019

Most influential descendants

Showing 2 of 2 · See all
  • K222543AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2…Steris · 2022 · cites it directly1descendant
  • K222849AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2…Steris · 2022 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−11K020875TSO3 Ozone Sterilizer, Model 125LTechnologies of Sterilization With Oxone, Tso3, Inc.2003—
−10K051595TSO3 Ozone Sterilizer, Model 125LTso3, Inc.2006—
−9K090636TSO3 Ozone Sterilizer, Model 125LTso3, Inc.2009—
−8K102330Amsco V-Pro Max Low Temperature Sterilization SystemSTERIS Corporation2011—
−7K112760Amsco V-Pro Max Low Temperature Sterilization SystemSTERIS Corporation2011—
−6K120632Amsco V-Pro 1 Low/Plus/Max Temperature Sterilization SystemSTERIS Corporation2012—
−5K131120Amsco V-Pro 1 Low, V-Pro 1 Plus, V-Pro Max Low Temperature Sterilization SystemSTERIS Corporation2013—
−4K160433V-PRO® 1 Plus and V-PRO® maX Low TemperatureSTERIS Corporation2016—
−3K162413AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1 Plus Low…STERIS Corporation20171
−2K172319AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1 Plus Low…STERIS Corporation20181
−1K182568V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature…STERIS Corporation2019—
0 (this device)K190917V-PRO 60 a Low Tempurature Strilization Systems, V-PRO s2 Low Temperature…STERIS Corporation2019—
+1K222543AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System…Steris2022—
+1K222849AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System…Steris2022—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200510
200710
200910
201120

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202220
FIG. 1 — Lineage of K190917, 2003–2022Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K250802 STERRAD® 100NX Sterilizer with ALLClear™…score 14.0 · 7 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K182568V-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…
STERIS Corporation2019—
†K190103V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature…STERIS Corporation2019—

Also cleared against K182568: 1 other device →

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K222543AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2…Steris20221
K222849AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2…Steris20220

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 3 companies; a new generation was cleared every 11 months on median.
  • 5 of the 16 ancestors have a recall of any class.
  • Of its descendants, K222543 (Steris, 2022) has gone furthest, with 1 descendant of its own.
  • 1 other device also cites its predicate K182568.

How does its category compare?

All MLR devices

MLR 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

2007: 22009: 12011: 62012: 22013: 12014: 22015: 12016: 42017: 22018: 22019: 42021: 22022: 22023: 52024: 32025: 12026 (partial year): 1
2007high 6 (2011) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MLR

216in 2024

2011: 214 days median2016: 183 days median2019: 90 days median2023: 222 days median2024: 216 days median
2007high 222 (2023) · low 90 (2019)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MLR

1in 2017

2007: 52008: 82009: 22010: 12011: 22012: 32013: 92014: 32017: 1
2007high 9 (2013) · low 0 (2015)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MLR

46in 2025

2007: 2722008: 5362009: 4332010: 2112011: 342012: 1012013: 5412014: 3992015: 4122016: 2862017: 2792018: 2892019: 2222020: 1742021: 2022022: 1882023: 1402024: 442025: 46
2007high 541 (2013) · low 34 (2011)2025

MAUDE reports naming product code MLR, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—5272
20080—8536
20091—2433
20100—1211
20116214234
20122—3101
20131—9541
20142—3399
20151—0412
201641830286
20172—1279
20182—0289
20194900222
20200—0174
20212—0202
20222—0188
202352220140
20243216044
20251—046
20261—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.

Also cleared against K182568

1 other device cites the same predicate.

  • K190027SteriStayToul Meditech AB · 2019

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205 FDA decisions under this applicant name. See the company

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Recent decisions in MLR

The MLR category page

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https://510kreport.com/device/K190917 · printed Nov 5, 2026

Cite this page

510(k) Report. “K190917: V-PRO 60 a Low Tempurature Strilization Systems, V-PRO s2 Low Temperature Sterilization Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K190917

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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