Cleared Traditional

K120632 - AMSCO V-PRO 1 LOW/PLUS/MAX TEMPERATURE STERILIZATION SYSTEM

K120632 is an FDA 510(k) clearance for AMSCO V-PRO 1 LOW/PLUS/MAX 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 117-day FDA review.

K120632 · STERIS Corporation · General Hospital
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Jun 2012
Decision
117d
Days
Class 2
Risk

K120632 is an FDA 510(k) clearance for the AMSCO V-PRO 1 LOW/PLUS/MAX TEMPERATURE STERILIZATION SYSTEM. Classified as Sterilizer, Chemical (product code MLR), Class II - Special Controls.

Submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on June 26, 2012 after a review of 117 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 - K120632

510(k) Number K120632 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2012
Decision Date June 26, 2012
Days to Decision 117 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 faster than avg
Panel avg: 129d · This submission: 117d
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 43
Devices cleared under the same product code (MLR) and FDA review panel - the closest regulatory comparables to K120632.
V-PRO 60 LOW TEMPERATURE STERILIZATION SYSTEM
K140498 · STERIS Corporation · Jul 2014
AMSCO V-PRO 1 LOW, V-PRO 1 PLUS, V-PRO MAX LOW TEMPERATURE STERILIZATION SYSTEM
K131120 · STERIS Corporation · Jul 2013
STERRAD(R) 100NX STERILIZER DUO CYCLE
K111377 · Advanced Sterilization Products · Sep 2012
AMSCO V-PRO MAX LOW TEMPERATURE STERILIZATION SYSTEM
K112760 · STERIS Corporation · Nov 2011
AMSCO V-PRO 1 AND V-PRO 1 PLUS LOW TEMPERATURE STERILIZATION UNITS
K111810 · STERIS Corporation · Sep 2011
AMSCO V-PRO 1 LOW TEMPERATURE STERILIZATION SYSTEM
K102394 · STERIS Corporation · Aug 2011