Cleared Traditional

K021360 - SCINTILLATING FIBER DOSIMETER (SFD), MODEL MT-SFD-1000

K021360 is an FDA 510(k) clearance for SCINTILLATING FIBER DOSIMETER (SFD), manufactured by Med-Tec,Inc.. The device is a Class 2 Radiology device with product code KXK cleared through the Traditional 510(k) pathway after a 406-day FDA review.

K021360 · Med-Tec,Inc. · Radiology device
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Jun 2003
Decision
406d
Days
Class 2
Risk

K021360 is an FDA 510(k) clearance for the SCINTILLATING FIBER DOSIMETER (SFD), MODEL MT-SFD-1000. Classified as Source, Brachytherapy, Radionuclide (product code KXK), Class II - Special Controls.

Submitted by Med-Tec,Inc. (Orange City, US). The FDA issued a Cleared decision on June 10, 2003 after a review of 406 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Radiology submissions.

View all Med-Tec,Inc. devices

FDA 510(k) Submission Details - K021360

510(k) Number K021360 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2002
Decision Date June 10, 2003
Days to Decision 406 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
299d slower than avg
Panel avg: 107d · This submission: 406d
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 58
Devices cleared under the same product code (KXK) and FDA review panel - the closest regulatory comparables to K021360.
BRACHYSOURCE BRACHYTHERAPY SEED IMPLANTS
K043246 · C.R. Bard, Inc. · Feb 2005
SOURCELINK
K041576 · C.R. Bard, Inc. · Jul 2004
CP SLEEVE AND RIVER SLEEVE
K034062 · Cp Medical · Jan 2004
VARISEED 7.1
K030534 · Varian Medical Systems · May 2003
GAMMAMED 212 AND 232 SOURCE ASSEMBLY
K030745 · Varian Medical Systems · Mar 2003
SYNTHETIC ABSORBABLE SEEDING SPACERS MADE OF POLYDIOXANONE MATERIAL
K021311 · Cp Medical · Jul 2002