Cleared Traditional

K150895 - SPEC Model M16

K150895 is an FDA 510(k) clearance for SPEC Model M16, manufactured by Source Production and Equipment Co., Inc.. The device is a Class 2 Radiology device with product code KXK cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K150895 · Source Production and Equipment Co., Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2015
Decision
78d
Days
Class 2
Risk

K150895 is an FDA 510(k) clearance for the SPEC Model M16. Classified as Source, Brachytherapy, Radionuclide (product code KXK), Class II - Special Controls.

Submitted by Source Production and Equipment Co., Inc. (Saint Rose, US). The FDA issued a Cleared decision on June 19, 2015 after a review of 78 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 - K150895

510(k) Number K150895 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 2015
Decision Date June 19, 2015
Days to Decision 78 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
29d faster than avg
Panel avg: 107d · This submission: 78d
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 K150895.
Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy Source
K162573 · Source Production and Equipment Co., Inc. · Nov 2016
SPEC Model M23
K161396 · Source Production and Equipment Co., Inc. · Aug 2016
SPEC Model M13
K161395 · Source Production and Equipment Co., Inc. · Jul 2016
VariSeed 9.0
K150636 · Varian Medical Systems, Inc. · May 2015
SMD Sr90-1 Radionuclide Brachytherapy Source
K142701 · Salutaris Medical Devices, Inc. · Dec 2014
I-125 RSLN [RADIOACTIVE SEED AND LOCALIZATION NEEDLE]
K141701 · Isoaid, LLC · Dec 2014