Cleared Special

K112813 - AMSCO V-PRO

K112813 is an FDA 510(k) clearance for AMSCO V-PRO, manufactured by Steris Corp. The device is a Class 2 General Hospital device with product code MLR cleared through the Special 510(k) pathway after a 65-day FDA review.

K112813 · Steris Corp · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2011
Decision
65d
Days
Class 2
Risk

K112813 is an FDA 510(k) clearance for the AMSCO V-PRO. Classified as Sterilizer, Chemical (product code MLR), Class II - Special Controls.

Submitted by Steris Corp (Mentor, US). The FDA issued a Cleared decision on December 1, 2011 after a review of 65 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6860 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K112813

510(k) Number K112813 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2011
Decision Date December 01, 2011
Days to Decision 65 days
Submission Type Special
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
64d faster than avg
Panel avg: 129d · This submission: 65d
Pathway characteristics
Modification to existing cleared device.

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 K112813.
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 1 LOW/PLUS/MAX TEMPERATURE STERILIZATION SYSTEM
K120632 · STERIS Corporation · Jun 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
K112813 · AMSCO V-PRO
Download PDF FDA Summary Steris Corp