Cleared Special

K190103 - V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 1 Plus Low Temperature Sterilization System, V-PRO 1 Low Temperature Sterilization System

K190103 is an FDA 510(k) clearance for V-PRO maX 2 Low Temperature Sterilizati..., manufactured by STERIS Corporation. The device is a Class 2 General Hospital device with product code MLR cleared through the Special 510(k) pathway after a 73-day FDA review.

K190103 · STERIS Corporation · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2019
Decision
73d
Days
Class 2
Risk

K190103 is an FDA 510(k) clearance for the V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature S.... Classified as Sterilizer, Chemical (product code MLR), Class II - Special Controls.

Submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on April 5, 2019 after a review of 73 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 - K190103

510(k) Number K190103 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 2019
Decision Date April 05, 2019
Days to Decision 73 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
56d faster than avg
Panel avg: 129d · This submission: 73d
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 47
Devices cleared under the same product code (MLR) and FDA review panel - the closest regulatory comparables to K190103.
STERRAD 100NX Sterilizer with ALLClear Technology
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K190005 · Sterilucent, Inc. · Sep 2019
V-PRO 60 a Low Tempurature Strilization Systems, V-PRO s2 Low Temperature Sterilization Systems
K190917 · STERIS Corporation · May 2019
V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System
K182568 · STERIS Corporation · Jan 2019
V-PRO maX 2 Low Temperature Sterilization System
K172754 · STERIS Corporation · Feb 2018
AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1 Plus Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System
K172319 · STERIS Corporation · Jan 2018
K190103 · V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 1 Plus Low Temperature Sterilization System, V-PRO 1 Low Temperature Sterilization System
Download PDF FDA Summary STERIS Corporation