Cleared Traditional

K922564 - 6 FRENCH CATHETER

K922564 is an FDA 510(k) clearance for 6 FRENCH CATHETER, manufactured by S. and H. Engineering, Inc.. The device is a Class 2 Radiology device with product code JAQ cleared through the Traditional 510(k) pathway after a 199-day FDA review.

K922564 · S. and H. Engineering, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1992
Decision
199d
Days
Class 2
Risk

K922564 is an FDA 510(k) clearance for the 6 FRENCH CATHETER. Classified as System, Applicator, Radionuclide, Remote-controlled (product code JAQ), Class II - Special Controls.

Submitted by S. and H. Engineering, Inc. (Miami, US). The FDA issued a Cleared decision on December 17, 1992 after a review of 199 days - an extended review cycle.

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. 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 S. and H. Engineering, Inc. devices

FDA 510(k) Submission Details - K922564

510(k) Number K922564 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 1992
Decision Date December 17, 1992
Days to Decision 199 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
92d slower than avg
Panel avg: 107d · This submission: 199d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JAQ Device Classification - Class 2, Special Controls

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

All 137
Devices cleared under the same product code (JAQ) and FDA review panel - the closest regulatory comparables to K922564.
APPLICATORS FOR VARIAN VARISOURCE REMOTE HIGH SOES RATE AFTERLOADER
K952913 · Varian Assoc., Inc. · Nov 1995
HIGH DOSE RATE AFTERLOADER
K945383 · Varian Assoc., Inc. · Feb 1995
HIGH DOSE RATE REMOTE AFTERLOADING CATHETER
K923738 · Cook, Inc. · Apr 1993
GAMMAMED IRIDIUM-192 SOURCE
K894381 · Mick Radio-Nuclear Instruments, Inc. · Nov 1989
GAMMAMED 12I
K891131 · Mick Radio-Nuclear Instruments, Inc. · Aug 1989
CURIETRON
K840127 · Syncor Intl. Corp. · Mar 1984