Cleared Traditional

K923107 - BODY BAND RESTRAINT STRAP SET

K923107 is an FDA 510(k) clearance for BODY BAND RESTRAINT STRAP SET, manufactured by Cook, Inc.. The device is a Class 2 Radiology device with product code JAA cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K923107 · Cook, Inc. · Radiology device
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Nov 1992
Decision
155d
Days
Class 2
Risk

K923107 is an FDA 510(k) clearance for the BODY BAND RESTRAINT STRAP SET. Classified as System, X-ray, Fluoroscopic, Image-intensified (product code JAA), Class II - Special Controls.

Submitted by Cook, Inc. (Ontario L4a 7x5, CA). The FDA issued a Cleared decision on November 27, 1992 after a review of 155 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K923107

510(k) Number K923107 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 1992
Decision Date November 27, 1992
Days to Decision 155 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d slower than avg
Panel avg: 107d · This submission: 155d
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 299
Devices cleared under the same product code (JAA) and FDA review panel - the closest regulatory comparables to K923107.
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DIGITAL FLUORO STORE
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MEDRAD PATHFINDER-E ROADMAPPING SYSTEM
K922274 · Medrad, Inc. · Oct 1992
K923107 · BODY BAND RESTRAINT STRAP SET
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