Cleared Traditional

K984446 - `BI I-125 BRACHYTHERAPHY SEED, MODEL 125SL & 125SH

K984446 is an FDA 510(k) clearance for `BI I-125 BRACHYTHERAPHY SEED, manufactured by Urocor, Inc.. The device is a Class 2 Radiology device with product code KXK cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K984446 · Urocor, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1999
Decision
123d
Days
Class 2
Risk

K984446 is an FDA 510(k) clearance for the `BI I-125 BRACHYTHERAPHY SEED, MODEL 125SL & 125SH. Classified as Source, Brachytherapy, Radionuclide (product code KXK), Class II - Special Controls.

Submitted by Urocor, Inc. (Oklahoma City, US). The FDA issued a Cleared decision on April 16, 1999 after a review of 123 days - within the typical 510(k) review window.

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: 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 Urocor, Inc. devices

FDA 510(k) Submission Details - K984446

510(k) Number K984446 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 1998
Decision Date April 16, 1999
Days to Decision 123 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
16d slower than avg
Panel avg: 107d · This submission: 123d
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 47
Devices cleared under the same product code (KXK) and FDA review panel - the closest regulatory comparables to K984446.
INTERSOURCE 125, MODEL 1251L
K984235 · International Brachytherapy, Inc. · Jun 1999
IODINE BRACHYTHERAPY SEEDS, MODEL 3000
K990193 · Implant Sciences Corp. · May 1999
UROMED BRACHYTHERAPHY IODINE-125 SOURCES
K982226 · Uromed Corp. · May 1999
INTERSOURCE
K973328 · International Brachytherapy S.A. · Dec 1998
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