Cleared Traditional

K994018 - PHARMASEED, MODEL BT-125-3

K994018 is an FDA 510(k) clearance for PHARMASEED, manufactured by Syncor Pharmaceuticals, Inc.. The device is a Class 2 Radiology device with product code KXK cleared through the Traditional 510(k) pathway after a 234-day FDA review.

K994018 · Syncor Pharmaceuticals, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2000
Decision
234d
Days
Class 2
Risk

K994018 is an FDA 510(k) clearance for the PHARMASEED, MODEL BT-125-3. Classified as Source, Brachytherapy, Radionuclide (product code KXK), Class II - Special Controls.

Submitted by Syncor Pharmaceuticals, Inc. (Golden, US). The FDA issued a Cleared decision on July 17, 2000 after a review of 234 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 Syncor Pharmaceuticals, Inc. devices

FDA 510(k) Submission Details - K994018

510(k) Number K994018 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 1999
Decision Date July 17, 2000
Days to Decision 234 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
127d slower than avg
Panel avg: 107d · This submission: 234d
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 48
Devices cleared under the same product code (KXK) and FDA review panel - the closest regulatory comparables to K994018.
ACCU-SPACE ABSORBABLE SEEDING SPACERS
K010621 · Cp Medical · Sep 2001
SELECT SEED I-125
K002429 · Nucletron Corp. · Feb 2001
LOOK COLLAGEN SPACERS, MODEL 1514B
K001765 · Surgical Specialties Corp · Sep 2000
125-IMPLANT SEEDS, MODEL STM1250
K991881 · Sourcetech Medical, LLC · Mar 2000
10 CURIE IRDIUM 192, CSN00100-192
K991571 · Alpha-Omega Services, Inc. · Feb 2000
PHARMASEED, MODEL BT-103-1
K992007 · Syncor Pharmaceuticals, Inc. · Jan 2000