Cleared Traditional

K940121 - IMPLANTERS/ADJUSTABLE/ANDERSON'S MARKERS

K940121 is an FDA 510(k) clearance for IMPLANTERS/ADJUSTABLE/ANDERSON'S MARKERS, manufactured by Best Industries. The device is a Class 1 Radiology device with product code IWJ cleared through the Traditional 510(k) pathway after a 354-day FDA review.

K940121 · Best Industries · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1994
Decision
354d
Days
Class 1
Risk

K940121 is an FDA 510(k) clearance for the IMPLANTERS/ADJUSTABLE/ANDERSON'S MARKERS. Classified as System, Applicator, Radionuclide, Manual (product code IWJ), Class I - General Controls.

Submitted by Best Industries (Springfield, US). The FDA issued a Cleared decision on December 30, 1994 after a review of 354 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5650 - 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 Best Industries devices

FDA 510(k) Submission Details - K940121

510(k) Number K940121 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 1994
Decision Date December 30, 1994
Days to Decision 354 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
247d slower than avg
Panel avg: 107d · This submission: 354d
Pathway characteristics
Predicate-based equivalence.

IWJ Device Classification - Class 1, General Controls

Product Code IWJ System, Applicator, Radionuclide, Manual
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.5650
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - IWJ System, Applicator, Radionuclide, Manual

All 23
Devices cleared under the same product code (IWJ) and FDA review panel - the closest regulatory comparables to K940121.
WEEKS APPLICATOR
K951052 · Duke University Medical Center · Aug 1996
MANAN PROSTATE LOCKING INTRODUCER SET
K961377 · Manan Medical Products, Inc. · Jul 1996
MORGANSTERN PROSTATE STABILIZATION AND SEEDING KIT
K944522 · Medical Device Technologies, Inc. · Feb 1995
COOK BRACH NEEDLE/RADIO DELIV CATH/FLEXI FLEXICATH
K940550 · Cook, Inc. · Aug 1994
QUICK SEEDER
K913293 · Mick Radio-Nuclear Instruments, Inc. · Oct 1992
WANG FRONT LOADING APPLICATOR
K890485 · Mick Radio-Nuclear Instruments, Inc. · Apr 1989