Home / 510(k) Clearances / K190917

510(k) K190917

V-PRO 60 a Low Tempurature Strilization Systems, V-PRO s2 Low Temperature Sterilization Systems by STERIS Corporation — Product Code MLR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 2019
Date Received
April 9, 2019
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sterilizer, Chemical
Device Class
Class II
Regulation Number
880.6860
Review Panel
HO
Submission Type

Other clearances by STERIS Corporation

  • K252680 — Celerity™ 20 HP Biological Indicator (September 24, 2025)
  • K251048 — Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118 (May 2, 2025)
  • K243876 — VERIFY STEAM Integrating Indicator (April 25, 2025)
  • K250842 — PADLOCK CLIP EFTR Kit (00713229) (April 18, 2025)
  • K250044 — Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB05 (February 6, 2025)
  • K250061 — Celerity Incubator (February 6, 2025)
  • K243475 — Chemical Indicator for enspire CLCSPS (LCC015) (December 4, 2024)
  • K243433 — enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System (December 2, 2024)
  • K243075 — Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323, 4000 (November 8, 2024)
  • K242742 — DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900) (October 11, 2024)

Other clearances for product code MLR

  • K250802 — STERRAD® 100NX Sterilizer with ALLClear™ Technology (10104) (April 14, 2025)
  • K231893 — LOWTEM Crystal 120 (September 18, 2024)
  • K234082 — STERRAD® 100NX Sterilizer with ALLClear™ Technology and ULTRA GI™ Cycle (10104); (July 5, 2024)
  • K233762 — SteroScope® Sterilization Technology System (June 27, 2024)
  • K233065 — V-PRO maX 2 Low Temperature Sterilization System (October 20, 2023)
  • K223476 — V-PRO maX 2 Low Temperature Sterilization System (August 7, 2023)
  • K231169 — STERLINK plus Sterilizer with STERLOAD Cassette, Tyvek Roll with CI for STERLINK (May 25, 2023)
  • K223015 — STERLINK™ FPS-15s Plus sterilizer with STERPACK™ plus cassette (May 9, 2023)
  • K220345 — STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll with CI for STE (April 14, 2023)
  • K222093 — V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Ster (September 9, 2022)