Cleared Traditional

K945983 - BEBIG INACTIVE OPHTHALMIC APPLICATORS FOR IODINE 125 SEEDS

K945983 is an FDA 510(k) clearance for BEBIG INACTIVE OPHTHALMIC APPLICATORS F..., manufactured by Bebig Trade, Inc.. The device is a Class 2 Radiology device with product code KXK cleared through the Traditional 510(k) pathway after a 314-day FDA review.

K945983 · Bebig Trade, Inc. · Radiology device
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Oct 1995
Decision
314d
Days
Class 2
Risk

K945983 is an FDA 510(k) clearance for the BEBIG INACTIVE OPHTHALMIC APPLICATORS FOR IODINE 125 SEEDS. Classified as Source, Brachytherapy, Radionuclide (product code KXK), Class II - Special Controls.

Submitted by Bebig Trade, Inc. (Chicago, US). The FDA issued a Cleared decision on October 18, 1995 after a review of 314 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Bebig Trade, Inc. devices

FDA 510(k) Submission Details - K945983

510(k) Number K945983 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 1994
Decision Date October 18, 1995
Days to Decision 314 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
207d slower than avg
Panel avg: 107d · This submission: 314d
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 107
Devices cleared under the same product code (KXK) and FDA review panel - the closest regulatory comparables to K945983.
INTERSOURCE
K973328 · International Brachytherapy S.A. · Dec 1998
NORTH AMERICAN SCIENTIFIC (NASI) I-125 RADIONUCLIDE BRACHYTHERAPY SOURCE- MODEL MED 3631-A
K972271 · Ml Strategies, Inc. · Oct 1997
NORTH AMERICAN SCIENTIFIC (NASI) 1-125 RADIONUCLIDE BRACHYTHERAPY SOURCE
K964647 · North American Scientific, Inc. · Feb 1997
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