Cleared Traditional

K142454 - STERRAD NX Sterilizer

K142454 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 213-day FDA review.

K142454 · Advanced Sterilization Products · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2015
Decision
213d
Days
Class 2
Risk

K142454 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 April 3, 2015 after a review of 213 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 K142454 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 2014
Decision Date April 03, 2015
Days to Decision 213 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
84d slower than avg
Panel avg: 129d · This submission: 213d
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 K142454.
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K131120 · STERIS Corporation · Jul 2013
STERRAD(R) 100NX STERILIZER DUO CYCLE
K111377 · Advanced Sterilization Products · Sep 2012