Cleared Traditional

K900740 - SPECIMEX DC

K900740 is an FDA 510(k) clearance for SPECIMEX DC, manufactured by Soredex Medical Systems. The device is a Class 2 Radiology device with product code GXZ cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K900740 · Soredex Medical Systems · Radiology device
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May 1990
Decision
84d
Days
Class 2
Risk

K900740 is an FDA 510(k) clearance for the SPECIMEX DC. Classified as Electrode, Needle (product code GXZ), Class II - Special Controls.

Submitted by Soredex Medical Systems (Conroe, US). The FDA issued a Cleared decision on May 11, 1990 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 882.1350 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Soredex Medical Systems devices

FDA 510(k) Submission Details - K900740

510(k) Number K900740 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 1990
Decision Date May 11, 1990
Days to Decision 84 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 107d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GXZ Device Classification - Class 2, Special Controls

Product Code GXZ Electrode, Needle
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1350
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 - GXZ Electrode, Needle

All 40
Devices cleared under the same product code (GXZ) and FDA review panel - the closest regulatory comparables to K900740.
GROUND/REFERENCE NEEDLE ELECTRODE
K933793 · Cadwell Laboratories, Inc. · Apr 1994
PROBLOC INSULATED NEEDLES
K926349 · Life-Tech Intl., Inc. · Jul 1993
BIO-DETEK EEG ELECTRODE
K920352 · Bio-Detek, Inc. · Aug 1992
DISP. CONCENTRIC NEEDLE ELECTRODE (DCP-30, DCP-45)
K896370 · Chalgren Enterprises, Inc. · Dec 1989
CONCENTRIC NEEDLE ELECTRODES-VARIOUS SIZES W/CONNE
K850107 · Nicolet Biomedical Instruments · Apr 1985
ELECTRODE, NEEDLE, CFM
K781311 · Applied Medical Research · Aug 1978