Cleared Traditional

K151725 - STERRAD NX Sterilizer

K151725 is the FDA 510(k) clearance for STERRAD NX Sterilizer by Advanced Sterilization Products. It is a Class 2 General Hospital device (product code MLR) cleared through the Traditional 510(k) pathway after a 201-day FDA review.

K151725 · Advanced Sterilization Products · General Hospital
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Jan 2016
Decision
201d
Days
Class 2
Risk

K151725 is an FDA 510(k) clearance for the STERRAD NX Sterilizer, STERRAD 100NX Sterilizer. Classified as Sterilizer, Chemical (product code MLR), Class II - Special Controls.

Submitted by Advanced Sterilization Products (Irvin, US). The FDA issued a Cleared decision on January 13, 2016 after a review of 201 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 Advanced Sterilization Products devices

Submission Details

510(k) Number K151725 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 2015
Decision Date January 13, 2016
Days to Decision 201 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
72d slower than avg
Panel avg: 129d · This submission: 201d
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 K151725.
STERRAD® NX Sterilizer with ALLClear™ Technology
K160818 · Advanced Sterilization Products · Sep 2016
STERRAD 100NX Sterilizer with ALLClearTM Technology
K160903 · Advanced Sterilization Products · Sep 2016
V-PRO® 1 Plus and V-PRO® maX Low Temperature
K160433 · STERIS Corporation · Jul 2016
STERRAD NX Sterilizer, STERRAD 100NX Sterilizer
K142454 · Advanced Sterilization Products · Apr 2015
V-PRO 60 LOW TEMPERATURE STERILIZATION SYSTEM
K140498 · STERIS Corporation · Jul 2014
AMSCO V-PRO 1 LOW, V-PRO 1 PLUS, V-PRO MAX LOW TEMPERATURE STERILIZATION SYSTEM
K131120 · STERIS Corporation · Jul 2013