Cleared Traditional

URETERAL COMPRESSION DEVICE (K931268) - FDA 510(k) Clearance

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

K931268 · Bt Medical Co., Inc. · Radiology device
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Jul 1993
Decision
133d
Days
Class 2
Risk

K931268 is an FDA 510(k) clearance for the URETERAL COMPRESSION DEVICE. Classified as System, X-ray, Fluoroscopic, Image-intensified (product code JAA), Class II - Special Controls.

Submitted by Bt Medical Co., Inc. (Bridgeport, US). The FDA issued a Cleared decision on July 19, 1993 after a review of 133 days - within the typical 510(k) review window.

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.

View all Bt Medical Co., Inc. devices

Submission Details

510(k) Number K931268 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 1993
Decision Date July 19, 1993
Days to Decision 133 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d slower than avg
Panel avg: 107d · This submission: 133d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 72
Devices cleared under the same product code (JAA) and FDA review panel - the closest regulatory comparables to K931268.
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SIRESKOP CX
K932445 · Siemens Medical Solutions USA, Inc. · Sep 1993
FLUOREX
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BODY BAND RESTRAINT STRAP SET
K923107 · Cook, Inc. · Nov 1992
ELECTRONIC PHOTOSPOT 20
K922240 · Toshiba America Medical Systems, In.C · Aug 1992