Cleared Traditional

ETHYLENE OXIDE STERILIZ. PARAMETRIC REL. (K822240) - FDA 510(k) Clearance

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

K822240 · American Mcgaw · Physical Medicine device
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Dec 1982
Decision
156d
Days
Class 2
Risk

K822240 is an FDA 510(k) clearance for the ETHYLENE OXIDE STERILIZ. PARAMETRIC REL.. Classified as Assembly, Thigh/knee/shank/ankle/foot, External (product code KFX), Class II - Special Controls.

Submitted by American Mcgaw (Santa Ana, US). The FDA issued a Cleared decision on December 30, 1982 after a review of 156 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3500 - the FDA physical medicine 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 Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all American Mcgaw devices

Submission Details

510(k) Number K822240 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1982
Decision Date December 30, 1982
Days to Decision 156 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d slower than avg
Panel avg: 115d · This submission: 156d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KFX Assembly, Thigh/knee/shank/ankle/foot, External
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.3500
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 Physical Medicine devices follow this clearance model.