Cleared Traditional

K172319 - AMSCO V-PRO 1 Low Temperature Steriliza...

K172319 is an FDA 510(k) clearance for AMSCO V-PRO 1 Low Temperature Steriliza..., manufactured by STERIS Corporation. The device is a Class 2 General Hospital device with product code MLR cleared through the Traditional 510(k) pathway after a 170-day FDA review.

K172319 · STERIS Corporation · General Hospital
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Jan 2018
Decision
170d
Days
Class 2
Risk

K172319 is an FDA 510(k) clearance for the AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1 Plus Low Te.... Classified as Sterilizer, Chemical (product code MLR), Class II - Special Controls.

Submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on January 18, 2018 after a review of 170 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

FDA 510(k) Submission Details - K172319

510(k) Number K172319 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2017
Decision Date January 18, 2018
Days to Decision 170 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
41d slower than avg
Panel avg: 129d · This submission: 170d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 43
Devices cleared under the same product code (MLR) and FDA review panel - the closest regulatory comparables to K172319.
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 · STERIS Corporation · Apr 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
K162413 · STERIS Corporation · Mar 2017
STERRAD NX Sterilizer
K162007 · Advanced Sterilization Products · Feb 2017
STERRAD® NX Sterilizer with ALLClear™ Technology
K160818 · Advanced Sterilization Products · Sep 2016