Cleared Traditional

K914825 - 1-125 ENDOSEED

K914825 is an FDA 510(k) clearance for 1-125 ENDOSEED, manufactured by Endo Technic Corp.. The device is a Class 2 Radiology device with product code KXK cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K914825 · Endo Technic Corp. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 1992
Decision
143d
Days
Class 2
Risk

K914825 is an FDA 510(k) clearance for the 1-125 ENDOSEED. Classified as Source, Brachytherapy, Radionuclide (product code KXK), Class II - Special Controls.

Submitted by Endo Technic Corp. (Omaha, US). The FDA issued a Cleared decision on March 19, 1992 after a review of 143 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K914825

510(k) Number K914825 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1991
Decision Date March 19, 1992
Days to Decision 143 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
36d slower than avg
Panel avg: 107d · This submission: 143d
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 150
Devices cleared under the same product code (KXK) and FDA review panel - the closest regulatory comparables to K914825.
RADIOACTIVE PALLADIUM 103 SEEDS/SOURCES
K930570 · Best Industries · Jun 1993
BRAINSCAN BRACHYTHERAPY MODULE
K920880 · Brainlab · Dec 1992
IR-192 IMPLANT -- MODIFICATION
K923130 · Omnitron Intl., Inc. · Sep 1992
I-125 SEEDS CODE: 6702
K915156 · Medi-Physics Inc. Dba Nycomed Amersham Imaging · Jan 1992
I-125 SEEDS IN CARRIER, CODE: 6720
K914268 · Medi-Physics Inc. Dba Nycomed Amersham Imaging · Nov 1991
I-125 SEEDS, CODE: 6711
K914281 · Medi-Physics Inc. Dba Nycomed Amersham Imaging · Nov 1991
K914825 · 1-125 ENDOSEED
Download PDF FDA Summary Endo Technic Corp.