Cleared Special

K190917 - V-PRO 60 a Low Tempurature Strilization Systems, V-PRO s2 Low Temperature Sterilization Systems

K190917 is an FDA 510(k) clearance for V-PRO 60 a Low Tempurature Strilization..., manufactured by STERIS Corporation. The device is a Class 2 General Hospital device with product code MLR cleared through the Special 510(k) pathway after a 30-day FDA review.

K190917 · STERIS Corporation · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2019
Decision
30d
Days
Class 2
Risk

K190917 is an FDA 510(k) clearance for the V-PRO 60 a Low Tempurature Strilization Systems, V-PRO s2 Low Temperature Ste.... Classified as Sterilizer, Chemical (product code MLR), Class II - Special Controls.

Submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on May 9, 2019 after a review of 30 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6860 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K190917

510(k) Number K190917 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 2019
Decision Date May 09, 2019
Days to Decision 30 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 129d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

MLR Device Classification - Class 2, Special Controls

Product Code MLR Sterilizer, Chemical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6860
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - MLR Sterilizer, Chemical

All 47
Devices cleared under the same product code (MLR) and FDA review panel - the closest regulatory comparables to K190917.
STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM Cassette
K212200 · Plasmapp Co,., Ltd. · Oct 2021
STERRAD 100NX Sterilizer with ALLClear Technology
K212174 · Advanced Sterilization Products, Inc. · Oct 2021
Sterilucent HC 80TT Hydrogen Peroxide Sterilizer
K190005 · Sterilucent, Inc. · Sep 2019
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
K190103 · STERIS Corporation · Apr 2019
V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System
K182568 · STERIS Corporation · Jan 2019
V-PRO maX 2 Low Temperature Sterilization System
K172754 · STERIS Corporation · Feb 2018
K190917 · V-PRO 60 a Low Tempurature Strilization Systems, V-PRO s2 Low Temperature Sterilization Systems
Download PDF FDA Summary STERIS Corporation