Cleared Traditional

K160433 - V-PRO® 1 Plus and V-PRO® maX Low Temperature

K160433 is an FDA 510(k) clearance for V-PRO 1 Plus and V-PRO maX Low Temperature, 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 141-day FDA review.

K160433 · STERIS Corporation · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2016
Decision
141d
Days
Class 2
Risk

K160433 is an FDA 510(k) clearance for the V-PRO® 1 Plus and V-PRO® maX Low Temperature. Classified as Sterilizer, Chemical (product code MLR), Class II - Special Controls.

Submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on July 6, 2016 after a review of 141 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.

FDA 510(k) Submission Details - K160433

510(k) Number K160433 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 2016
Decision Date July 06, 2016
Days to Decision 141 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
12d slower than avg
Panel avg: 129d · This submission: 141d
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 46
Devices cleared under the same product code (MLR) and FDA review panel - the closest regulatory comparables to K160433.
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K151725 · Advanced Sterilization Products · Jan 2016
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K142454 · Advanced Sterilization Products · Apr 2015
STERILUCENT PSD-85 HYDROGEN PEROXIDE STERILIZER
K140464 · Sterilucent, Inc. · Oct 2014