Cleared Traditional

K083097 - AMSCO V-PRO 1 LOW TEMPERATURE STERILIZA...

K083097 is the FDA 510(k) clearance for AMSCO V-PRO 1 LOW TEMPERATURE STERILIZA... by STERIS Corporation. It is a Class 2 General Hospital device (product code MLR) cleared through the Traditional 510(k) pathway after a 290-day FDA review.

K083097 · STERIS Corporation · General Hospital
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Aug 2009
Decision
290d
Days
Class 2
Risk

K083097 is an FDA 510(k) clearance for the AMSCO V-PRO 1 LOW 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 August 3, 2009 after a review of 290 days - an extended review cycle.

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

Submission Details

510(k) Number K083097 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 2008
Decision Date August 03, 2009
Days to Decision 290 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
161d slower than avg
Panel avg: 129d · This submission: 290d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 42
Devices cleared under the same product code (MLR) and FDA review panel - the closest regulatory comparables to K083097.
AMSCO V-PRO 1 LOW TEMPERATURE STERILIZATION SYSTEM
K102394 · STERIS Corporation · Aug 2011
AMSCO V-PRO MAX LOW TEMPERATURE STERILIZATION SYSTEM
K102330 · STERIS Corporation · Aug 2011
STERRAD 100NX STERILIZER EXPRESS CYCLE
K092622 · Advanced Sterilization Products · Mar 2011
STERRAD 100NX STERILIZER
K071385 · Advanced Sterilization Products · Nov 2007
VHP 136 LOW TEMPERATURE STERILIZATION SYSTEM
K062297 · STERIS Corporation · Oct 2007
STERRAD NX STERILIZER
K042116 · Advanced Sterilization Products · Apr 2005