Cleared Traditional

AMSCO V-PRO 1 LOW TEMPERATURE STERILIZATION SYSTEM (K102394) - FDA 510(k) Clearance

Also marketed or referenced as:
AMSCO V-PRO 1 PLUS LOW TEMPERATURE STERILIZATION SYSTEM

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K102394 · STERIS Corporation · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2011
Decision
360d
Days
Class 2
Risk

K102394 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 18, 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 K102394 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 2010
Decision Date August 18, 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
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 46
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