Cleared Traditional

K850959 - EQUIPMENT SNAP KOVERS

K850959 is an FDA 510(k) clearance for EQUIPMENT SNAP KOVERS, manufactured by Advance Medical Designs, Inc.. The device is a Class 2 Radiology device with product code JAA cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K850959 · Advance Medical Designs, Inc. · Radiology device
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Apr 1985
Decision
32d
Days
Class 2
Risk

K850959 is an FDA 510(k) clearance for the EQUIPMENT SNAP KOVERS. Classified as System, X-ray, Fluoroscopic, Image-intensified (product code JAA), Class II - Special Controls.

Submitted by Advance Medical Designs, Inc. (Marietta, US). The FDA issued a Cleared decision on April 9, 1985 after a review of 32 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1650 - 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 Advance Medical Designs, Inc. devices

FDA 510(k) Submission Details - K850959

510(k) Number K850959 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 1985
Decision Date April 09, 1985
Days to Decision 32 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 107d · This submission: 32d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JAA Device Classification - Class 2, Special Controls

Product Code JAA System, X-ray, Fluoroscopic, Image-intensified
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1650
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 Radiology devices follow this clearance model.

Regulatory Peers - JAA System, X-ray, Fluoroscopic, Image-intensified

All 146
Devices cleared under the same product code (JAA) and FDA review panel - the closest regulatory comparables to K850959.
SCX SYSTEM
K862120 · General Electric Co. · Jun 1986
PET-SCOPE II IMAGE INTENSIFIER
K855213 · Philips Medical Systems (Cleveland), Inc. · Jan 1986
CANON X-RAY IMAGE DISTRIBUTOR
K853984 · Canon USA, Inc. · Oct 1985
REGISTREX 1000 PLUS DIGITAL RADIOGRAPHY
K840364 · Advanced Technology Laboratories, Inc. · Mar 1984
DIGITAL FLUOROGRAPHY X-RAY SYSTEM
K840191 · Adac Laboratories · Mar 1984
TECHNICARE MODEL 1047
K840390 · Technicare Corp. · Feb 1984