Cleared Traditional

K904185 - SENSATRACE

K904185 is an FDA 510(k) clearance for SENSATRACE, manufactured by Ludlow Corp., Technical Papers Division. The device is a Class 2 Cardiovascular device with product code DRX cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K904185 · Ludlow Corp., Technical Papers Division · Cardiovascular device
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Oct 1990
Decision
49d
Days
Class 2
Risk

K904185 is an FDA 510(k) clearance for the SENSATRACE. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Ludlow Corp., Technical Papers Division (Chicopee, US). The FDA issued a Cleared decision on October 31, 1990 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2360 - the FDA cardiovascular device 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 Ludlow Corp., Technical Papers Division devices

FDA 510(k) Submission Details - K904185

510(k) Number K904185 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 1990
Decision Date October 31, 1990
Days to Decision 49 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 125d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRX Device Classification - Class 2, Special Controls

Product Code DRX Electrode, Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2360
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DRX Electrode, Electrocardiograph

All 195
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K904185.
CANMED 451
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SILVER MACTRODE
K902176 · Marquette Electronics, Inc. · Sep 1990
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K902738 · Labeltape Meditect, Inc. · Sep 1990
MODEL 1730 NEOTRODE WITH ATTACHED LEADWIRE
K901555 · Medtronic Vascular · Jul 1990