Cleared Traditional

K930314 - HEARTLINE TRANSTELEPHONIC ECG RECEIVING CONSOLE

K930314 is an FDA 510(k) clearance for HEARTLINE TRANSTELEPHONIC ECG RECEIVING..., manufactured by Aerotel, Ltd.. The device is a Class 2 Cardiovascular device with product code DXH cleared through the Traditional 510(k) pathway after a 420-day FDA review.

K930314 · Aerotel, Ltd. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 1994
Decision
420d
Days
Class 2
Risk

K930314 is an FDA 510(k) clearance for the HEARTLINE TRANSTELEPHONIC ECG RECEIVING CONSOLE. Classified as Transmitters And Receivers, Electrocardiograph, Telephone (product code DXH), Class II - Special Controls.

Submitted by Aerotel, Ltd. (Israel, IL). The FDA issued a Cleared decision on March 18, 1994 after a review of 420 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

FDA 510(k) Submission Details - K930314

510(k) Number K930314 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 1993
Decision Date March 18, 1994
Days to Decision 420 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
295d slower than avg
Panel avg: 125d · This submission: 420d
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 248
Devices cleared under the same product code (DXH) and FDA review panel - the closest regulatory comparables to K930314.
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K932863 · Coherent Systems, Inc. · Mar 1994
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K933012 · Medical Electronic Record Exchange · Mar 1994
CORFAX CARDIAC DATA TRANSMITTER
K931585 · Ralin Medical, Inc. · Mar 1994
K930314 · HEARTLINE TRANSTELEPHONIC ECG RECEIVING CONSOLE
Download PDF FDA Summary Aerotel, Ltd.