Cleared Traditional

K011205 - ISOAID IODINE BRACHTHERAPY SEEDS, MODEL ADVANTAGE I-125

K011205 is an FDA 510(k) clearance for ISOAID IODINE BRACHTHERAPY SEEDS, manufactured by Isoaid. The device is a Class 2 Radiology device with product code KXK cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K011205 · Isoaid · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2001
Decision
82d
Days
Class 2
Risk

K011205 is an FDA 510(k) clearance for the ISOAID IODINE BRACHTHERAPY SEEDS, MODEL ADVANTAGE I-125. Classified as Source, Brachytherapy, Radionuclide (product code KXK), Class II - Special Controls.

Submitted by Isoaid (Appollo Beach, US). The FDA issued a Cleared decision on July 10, 2001 after a review of 82 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 Isoaid devices

FDA 510(k) Submission Details - K011205

510(k) Number K011205 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 2001
Decision Date July 10, 2001
Days to Decision 82 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
25d faster than avg
Panel avg: 107d · This submission: 82d
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 79
Devices cleared under the same product code (KXK) and FDA review panel - the closest regulatory comparables to K011205.
CP-SLEEVE
K013975 · Cp Medical · Feb 2002
MODIFICATION TO ACCU-SPACE PLAIN GUT ABSORBABLE SEEDING SPACERS
K013964 · Cp Medical · Jan 2002
ACCU-SPACE ABSORBABLE SEEDING SPACERS
K010621 · Cp Medical · Sep 2001
SELECT SEED I-125
K002429 · Nucletron Corp. · Feb 2001
LOOK COLLAGEN SPACERS, MODEL 1514B
K001765 · Surgical Specialties Corp · Sep 2000
PHARMASEED, MODEL BT-125-3
K994018 · Syncor Pharmaceuticals, Inc. · Jul 2000