Cleared Traditional

K252843 - STERRAD 100NX Sterilization System with ALLClear Technology (10104) (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K252843 · Advanced Sterilization Products, Inc. · General Hospital
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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

Submission Details

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
91d slower than avg
Panel avg: 128d · This submission: 219d
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 46
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