Cleared Traditional

K911775 - OMNICATH IMPLANTED CATHETER AND DEPOT

K911775 is an FDA 510(k) clearance for OMNICATH IMPLANTED CATHETER AND DEPOT, manufactured by Omnitron Intl., Inc.. The device is a Class 2 Radiology device with product code KXK cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K911775 · Omnitron Intl., Inc. · Radiology device
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May 1991
Decision
37d
Days
Class 2
Risk

K911775 is an FDA 510(k) clearance for the OMNICATH IMPLANTED CATHETER AND DEPOT. Classified as Source, Brachytherapy, Radionuclide (product code KXK), Class II - Special Controls.

Submitted by Omnitron Intl., Inc. (Houston, US). The FDA issued a Cleared decision on May 8, 1991 after a review of 37 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5730 - 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 Omnitron Intl., Inc. devices

FDA 510(k) Submission Details - K911775

510(k) Number K911775 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1991
Decision Date May 08, 1991
Days to Decision 37 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 107d · This submission: 37d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KXK Device Classification - Class 2, Special Controls

Product Code KXK Source, Brachytherapy, Radionuclide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5730
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 - KXK Source, Brachytherapy, Radionuclide

All 108
Devices cleared under the same product code (KXK) and FDA review panel - the closest regulatory comparables to K911775.
NORTH AMERICAN SCIENTIFIC (NASI) I-125 RADIONUCLIDE BRACHYTHERAPY SOURCE- MODEL MED 3631-A
K972271 · Ml Strategies, Inc. · Oct 1997
NORTH AMERICAN SCIENTIFIC (NASI) 1-125 RADIONUCLIDE BRACHYTHERAPY SOURCE
K964647 · North American Scientific, Inc. · Feb 1997
RADIONUCLIDE CATHETERS, RNC-A, RNC-G, RNC-U
K923697 · Radionics, Inc. · Dec 1993
MANAN PROSTATE SEEDING NEEDLE
K902622 · Manan Medical Products, Inc. · Aug 1990
CESIUM 137 ENDOMETRIAL SOURCE
K850433 · Syncor Intl. Corp. · Aug 1985
CESIUM 137 SOURCE, CSM-4, CSM-11, CSM-41
K852023 · Syncor Intl. Corp. · Aug 1985