Cleared Traditional

K991571 - 10 CURIE IRDIUM 192, CSN00100-192

K991571 is an FDA 510(k) clearance for 10 CURIE IRDIUM 192, manufactured by Alpha-Omega Services, Inc.. The device is a Class 2 Radiology device with product code KXK cleared through the Traditional 510(k) pathway after a 293-day FDA review.

K991571 · Alpha-Omega Services, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2000
Decision
293d
Days
Class 2
Risk

K991571 is an FDA 510(k) clearance for the 10 CURIE IRDIUM 192, CSN00100-192. Classified as Source, Brachytherapy, Radionuclide (product code KXK), Class II - Special Controls.

Submitted by Alpha-Omega Services, Inc. (Houston, US). The FDA issued a Cleared decision on February 22, 2000 after a review of 293 days - an extended review 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: 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 Alpha-Omega Services, Inc. devices

FDA 510(k) Submission Details - K991571

510(k) Number K991571 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 1999
Decision Date February 22, 2000
Days to Decision 293 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
186d slower than avg
Panel avg: 107d · This submission: 293d
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 137
Devices cleared under the same product code (KXK) and FDA review panel - the closest regulatory comparables to K991571.
I-PLANT, MODEL 3500
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125-IMPLANT SEEDS, MODEL STM1250
K991881 · Sourcetech Medical, LLC · Mar 2000
PROSTEC 125I BRACHYTHERAPY SEEDS
K993280 · Prostec, LLC · Mar 2000
PHARMASEED, MODEL BT-103-1
K992007 · Syncor Pharmaceuticals, Inc. · Jan 2000
PHARMASEED, MODEL BT-125-1
K992008 · Syncor Pharmaceuticals, Inc. · Dec 1999
WORLDWIDE MEDICAL TECHNOLOGIES SEEDING SPACERS
K991344 · Worldwide Medical Technologies, LLC · Nov 1999