Cleared Traditional

K142701 - SMD Sr90-1 Radionuclide Brachytherapy Source

K142701 is an FDA 510(k) clearance for SMD Sr90-1 Radionuclide Brachytherapy S..., manufactured by Salutaris Medical Devices, Inc.. The device is a Class 2 Radiology device with product code KXK cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K142701 · Salutaris Medical Devices, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2014
Decision
88d
Days
Class 2
Risk

K142701 is an FDA 510(k) clearance for the SMD Sr90-1 Radionuclide Brachytherapy Source. Classified as Source, Brachytherapy, Radionuclide (product code KXK), Class II - Special Controls.

Submitted by Salutaris Medical Devices, Inc. (Tucson, US). The FDA issued a Cleared decision on December 19, 2014 after a review of 88 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.

FDA 510(k) Submission Details - K142701

510(k) Number K142701 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2014
Decision Date December 19, 2014
Days to Decision 88 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 107d · This submission: 88d
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 140
Devices cleared under the same product code (KXK) and FDA review panel - the closest regulatory comparables to K142701.
SPEC Model M13
K161395 · Source Production and Equipment Co., Inc. · Jul 2016
SPEC Model M16
K150895 · Source Production and Equipment Co., Inc. · Jun 2015
VariSeed 9.0
K150636 · Varian Medical Systems, Inc. · May 2015
I-125 RSLN [RADIOACTIVE SEED AND LOCALIZATION NEEDLE]
K141701 · Isoaid, LLC · Dec 2014
Lesion-Loc Iodine I-125 Seed/Needle
K142668 · Intramedical Imaging, LLC · Nov 2014
ANT MODEL 1
K141038 · Advanced Nuclide Technologies, LLC · Nov 2014