Cleared Traditional

STERRAD 100NX Sterilizer with ALLClear Technology (K212174) - FDA 510(k) Clearance

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

K212174 · Advanced Sterilization Products, Inc. · General Hospital
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Oct 2021
Decision
89d
Days
Class 2
Risk

K212174 is an FDA 510(k) clearance for the STERRAD 100NX Sterilizer with ALLClear Technology. 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 October 9, 2021 after a review of 89 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Advanced Sterilization Products, Inc. devices

Submission Details

510(k) Number K212174 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 2021
Decision Date October 09, 2021
Days to Decision 89 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
40d faster than avg
Panel avg: 129d · This submission: 89d
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 30
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