Cleared Traditional

K130757 - KOBOLD SECURE LOCK TRANSFER GUIDE TUBE SET (FDA 510(k) Clearance)

Also includes:
KOBOLD LUER TRANSFER GUIDE TUBE SET

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

K130757 · Spencer Fillmore · Radiology device
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Apr 2014
Decision
379d
Days
Class 2
Risk

K130757 is an FDA 510(k) clearance for the KOBOLD SECURE LOCK TRANSFER GUIDE TUBE SET. Classified as System, Applicator, Radionuclide, Remote-controlled (product code JAQ), Class II - Special Controls.

Submitted by Spencer Fillmore (San Francisco, US). The FDA issued a Cleared decision on April 3, 2014 after a review of 379 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5700 - 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. Elevated predicate reliance profile. 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 Spencer Fillmore devices

Submission Details

510(k) Number K130757 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 2013
Decision Date April 03, 2014
Days to Decision 379 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
272d slower than avg
Panel avg: 107d · This submission: 379d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JAQ System, Applicator, Radionuclide, Remote-controlled
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5700
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 - JAQ System, Applicator, Radionuclide, Remote-controlled

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