Cleared Traditional

K931585 - CORFAX CARDIAC DATA TRANSMITTER

K931585 is an FDA 510(k) clearance for CORFAX CARDIAC DATA TRANSMITTER, manufactured by Ralin Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DXH cleared through the Traditional 510(k) pathway after a 341-day FDA review.

K931585 · Ralin Medical, Inc. · Cardiovascular device
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Mar 1994
Decision
341d
Days
Class 2
Risk

K931585 is an FDA 510(k) clearance for the CORFAX CARDIAC DATA TRANSMITTER. Classified as Transmitters And Receivers, Electrocardiograph, Telephone (product code DXH), Class II - Special Controls.

Submitted by Ralin Medical, Inc. (Beaverton, US). The FDA issued a Cleared decision on March 7, 1994 after a review of 341 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2920 - 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Ralin Medical, Inc. devices

FDA 510(k) Submission Details - K931585

510(k) Number K931585 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 1993
Decision Date March 07, 1994
Days to Decision 341 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
216d slower than avg
Panel avg: 125d · This submission: 341d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXH Device Classification - Class 2, Special Controls

Product Code DXH Transmitters And Receivers, Electrocardiograph, Telephone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2920
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 - DXH Transmitters And Receivers, Electrocardiograph, Telephone

All 190
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