Cleared Traditional

K071385 - STERRAD 100NX STERILIZER

K071385 is an FDA 510(k) clearance for STERRAD 100NX STERILIZER, manufactured by Advanced Sterilization Products. The device is a Class 2 General Hospital device with product code MLR cleared through the Traditional 510(k) pathway after a 195-day FDA review.

K071385 · Advanced Sterilization Products · General Hospital
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Nov 2007
Decision
195d
Days
Class 2
Risk

K071385 is an FDA 510(k) clearance for the STERRAD 100NX STERILIZER. 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 November 29, 2007 after a review of 195 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

FDA 510(k) Submission Details - K071385

510(k) Number K071385 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 2007
Decision Date November 29, 2007
Days to Decision 195 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
66d slower than avg
Panel avg: 129d · This submission: 195d
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 45
Devices cleared under the same product code (MLR) and FDA review panel - the closest regulatory comparables to K071385.
AMSCO V-PRO MAX LOW TEMPERATURE STERILIZATION SYSTEM
K102330 · STERIS Corporation · Aug 2011
STERRAD 100NX STERILIZER EXPRESS CYCLE
K092622 · Advanced Sterilization Products · Mar 2011
AMSCO V-PRO 1 LOW TEMPERATURE STERILIZATION SYSTEM
K083097 · STERIS Corporation · Aug 2009
VHP 136 LOW TEMPERATURE STERILIZATION SYSTEM
K062297 · STERIS Corporation · Oct 2007
STERRAD NX STERILIZER
K042116 · Advanced Sterilization Products · Apr 2005
STERRAD 200 STERILIZER
K030429 · Advanced Sterilization Products · Aug 2003