Cleared Traditional

K252843 - STERRAD 100NX Sterilization System with ALLClear Technology (10104)

K252843 is an FDA 510(k) clearance for STERRAD 100NX Sterilization System with..., manufactured by Advanced Sterilization Products, Inc.. The device is a Class 2 General Hospital device with product code MLR cleared through the Traditional 510(k) pathway after a 219-day FDA review.

K252843 · Advanced Sterilization Products, Inc. · General Hospital
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Optimized for regulatory review, auditing and printing
Apr 2026
Decision
219d
Days
Class 2
Risk

K252843 is an FDA 510(k) clearance for the STERRAD 100NX Sterilization System with ALLClear Technology (10104). Classified as Sterilizer, Chemical (product code MLR), Class II - Special Controls.

Submitted by Advanced Sterilization Products, Inc. (Irvin, US). The FDA issued a Cleared decision on April 15, 2026 after a review of 219 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, Inc. devices

FDA 510(k) Submission Details - K252843

510(k) Number K252843 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 2025
Decision Date April 15, 2026
Days to Decision 219 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
90d slower than avg
Panel avg: 129d · This submission: 219d
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 K252843.
STERRAD® 100NX Sterilizer with ALLClear™ Technology (10104)
K250802 · Advanced Sterilization Products, Inc. · Apr 2025
LOWTEM Crystal 120
K231893 · Lowtem Co., Ltd. · Sep 2024
STERRAD® 100NX Sterilizer with ALLClear™ Technology and ULTRA GI™ Cycle (10104)
K234082 · Advanced Sterilization Products · Jul 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