Cleared Traditional

K102330 - AMSCO V-PRO MAX LOW TEMPERATURE STERILI...

K102330 is the FDA 510(k) clearance for AMSCO V-PRO MAX LOW TEMPERATURE STERILI... by STERIS Corporation. It is a Class 2 General Hospital device (product code MLR) cleared through the Traditional 510(k) pathway after a 360-day FDA review.

K102330 · STERIS Corporation · General Hospital
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Aug 2011
Decision
360d
Days
Class 2
Risk

K102330 is an FDA 510(k) clearance for the AMSCO V-PRO MAX 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 12, 2011 after a review of 360 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 K102330 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 2010
Decision Date August 12, 2011
Days to Decision 360 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
231d slower than avg
Panel avg: 129d · This submission: 360d
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 K102330.
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
STERRAD 100NX STERILIZER EXPRESS CYCLE
K092622 · Advanced Sterilization Products · Mar 2011
AMSCO V-PRO 1 LOW TEMPERATURE STERILIZATION SYSTEM
K083097 · STERIS Corporation · Aug 2009
STERRAD 100NX STERILIZER
K071385 · Advanced Sterilization Products · Nov 2007