Cleared Traditional

K822240 - ETHYLENE OXIDE STERILIZ. PARAMETRIC REL.

K822240 is an FDA 510(k) clearance for ETHYLENE OXIDE STERILIZ. PARAMETRIC REL., manufactured by American Mcgaw. The device is a Class 2 Physical Medicine device with product code KFX cleared through the Traditional 510(k) pathway after a 156-day FDA review.

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

FDA 510(k) Submission Details - K822240

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.

KFX Device Classification - Class 2, Special Controls

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.