Cleared Traditional

K160818 - STERRAD NX Sterilizer with ALLClear Tec...

K160818 is the FDA 510(k) clearance for STERRAD NX Sterilizer with ALLClear Tec... by Advanced Sterilization Products. It is a Class 2 General Hospital device (product code MLR) cleared through the Traditional 510(k) pathway after a 187-day FDA review.

K160818 · Advanced Sterilization Products · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2016
Decision
187d
Days
Class 2
Risk

K160818 is an FDA 510(k) clearance for the STERRAD® NX Sterilizer with ALLClear™ Technology. Classified as Sterilizer, Chemical (product code MLR), Class II - Special Controls.

Submitted by Advanced Sterilization Products (Irvine, US). The FDA issued a Cleared decision on September 27, 2016 after a review of 187 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 K160818 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 2016
Decision Date September 27, 2016
Days to Decision 187 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
58d slower than avg
Panel avg: 129d · This submission: 187d
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 K160818.
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
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 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
K151725 · Advanced Sterilization Products · Jan 2016