Cleared Traditional

K863890 - MAMM-AIRE (FDA 510(k) Clearance)

Class I Radiology device.

K863890 · Ar Custom Medical Products, Ltd. · Radiology device
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Oct 1986
Decision
8d
Days
Class 1
Risk

K863890 is an FDA 510(k) clearance for the MAMM-AIRE. Classified as Cradle, Patient, Radiologic (product code KXH), Class I - General Controls.

Submitted by Ar Custom Medical Products, Ltd. (Deer Park, US). The FDA issued a Cleared decision on October 14, 1986 after a review of 8 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1830 - the FDA radiology and imaging software oversight 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 Ar Custom Medical Products, Ltd. devices

Submission Details

510(k) Number K863890 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 1986
Decision Date October 14, 1986
Days to Decision 8 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 107d · This submission: 8d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KXH Cradle, Patient, Radiologic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1830
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.