Cleared Traditional

K991344 - WORLDWIDE MEDICAL TECHNOLOGIES SEEDING ...

K991344 is an FDA 510(k) clearance for WORLDWIDE MEDICAL TECHNOLOGIES SEEDING ..., manufactured by Worldwide Medical Technologies, LLC. The device is a Class 2 Radiology device with product code KXK cleared through the Traditional 510(k) pathway after a 200-day FDA review.

K991344 · Worldwide Medical Technologies, LLC · Radiology device
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Nov 1999
Decision
200d
Days
Class 2
Risk

K991344 is an FDA 510(k) clearance for the WORLDWIDE MEDICAL TECHNOLOGIES SEEDING SPACERS. Classified as Source, Brachytherapy, Radionuclide (product code KXK), Class II - Special Controls.

Submitted by Worldwide Medical Technologies, LLC (Woodbury, US). The FDA issued a Cleared decision on November 5, 1999 after a review of 200 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 Worldwide Medical Technologies, LLC devices

FDA 510(k) Submission Details - K991344

510(k) Number K991344 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 1999
Decision Date November 05, 1999
Days to Decision 200 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
93d slower than avg
Panel avg: 107d · This submission: 200d
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 32
Devices cleared under the same product code (KXK) and FDA review panel - the closest regulatory comparables to K991344.
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K013964 · Cp Medical · Jan 2002
ACCU-SPACE ABSORBABLE SEEDING SPACERS
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SELECT SEED I-125
K002429 · Nucletron Corp. · Feb 2001
RADIONUCLIDE CATHETERS, RNC-A, RNC-G, RNC-U
K923697 · Radionics, Inc. · Dec 1993
MANAN PROSTATE SEEDING NEEDLE
K902622 · Manan Medical Products, Inc. · Aug 1990
CESIUM 137 ENDOMETRIAL SOURCE
K850433 · Syncor Intl. Corp. · Aug 1985