Cleared Traditional

K234082 - STERRAD 100NX Sterilizer with ALLClear ...

Also marketed or referenced as:
APTIMAX™ Instrument Tray for ULTRA GI™ Cycle (011077)

K234082 is an FDA 510(k) clearance for STERRAD 100NX Sterilizer with ALLClear ..., 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 196-day FDA review.

K234082 · Advanced Sterilization Products · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2024
Decision
196d
Days
Class 2
Risk

K234082 is an FDA 510(k) clearance for the STERRAD® 100NX Sterilizer with ALLClear™ Technology and ULTRA GI™ Cycle (10104). 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 July 5, 2024 after a review of 196 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 - K234082

510(k) Number K234082 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2023
Decision Date July 05, 2024
Days to Decision 196 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
67d slower than avg
Panel avg: 129d · This submission: 196d
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 42
Devices cleared under the same product code (MLR) and FDA review panel - the closest regulatory comparables to K234082.
STERRAD 100NX Sterilization System with ALLClear Technology (10104)
K252843 · Advanced Sterilization Products, Inc. · Apr 2026
STERRAD® 100NX Sterilizer with ALLClear™ Technology (10104)
K250802 · Advanced Sterilization Products, Inc. · Apr 2025
LOWTEM Crystal 120
K231893 · Lowtem Co., Ltd. · Sep 2024
SteroScope® Sterilization Technology System
K233762 · Ideate Medical, Inc. · Jun 2024
V-PRO maX 2 Low Temperature Sterilization System
K233065 · Steris · Oct 2023
V-PRO maX 2 Low Temperature Sterilization System
K223476 · STERIS Corporation · Aug 2023