Cleared Traditional

K182568 - V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System

K182568 is an FDA 510(k) clearance for V-PRO s2 Low Temperature Sterilization ..., manufactured by STERIS Corporation. The device is a Class 2 General Hospital device with product code MLR cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K182568 · STERIS Corporation · General Hospital
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Jan 2019
Decision
107d
Days
Class 2
Risk

K182568 is an FDA 510(k) clearance for the V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Steri.... Classified as Sterilizer, Chemical (product code MLR), Class II - Special Controls.

Submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on January 3, 2019 after a review of 107 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6860 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all STERIS Corporation devices

FDA 510(k) Submission Details - K182568

510(k) Number K182568 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 2018
Decision Date January 03, 2019
Days to Decision 107 days
Submission Type Traditional
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
22d faster than avg
Panel avg: 129d · This submission: 107d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 45
Devices cleared under the same product code (MLR) and FDA review panel - the closest regulatory comparables to K182568.
Sterilucent HC 80TT Hydrogen Peroxide Sterilizer
K190005 · Sterilucent, Inc. · Sep 2019
V-PRO 60 a Low Tempurature Strilization Systems, V-PRO s2 Low Temperature Sterilization Systems
K190917 · STERIS Corporation · May 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 maX 2 Low Temperature Sterilization System
K172754 · STERIS Corporation · Feb 2018
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
K172319 · STERIS Corporation · Jan 2018
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
K162413 · STERIS Corporation · Mar 2017