Cleared Special

K022073 - HEARTLINE RECEIVING STATION

K022073 is an FDA 510(k) clearance for HEARTLINE RECEIVING STATION, manufactured by Aerotel Medical Systems (1998) , Ltd.. The device is a Class 2 Cardiovascular device with product code DXH cleared through the Special 510(k) pathway after a 28-day FDA review.

K022073 · Aerotel Medical Systems (1998) , Ltd. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2002
Decision
28d
Days
Class 2
Risk

K022073 is an FDA 510(k) clearance for the HEARTLINE RECEIVING STATION. Classified as Transmitters And Receivers, Electrocardiograph, Telephone (product code DXH), Class II - Special Controls.

Submitted by Aerotel Medical Systems (1998) , Ltd. (Hasbrouck Heights, US). The FDA issued a Cleared decision on July 24, 2002 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2920 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K022073

510(k) Number K022073 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 2002
Decision Date July 24, 2002
Days to Decision 28 days
Submission Type Special
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
97d faster than avg
Panel avg: 125d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 296
Devices cleared under the same product code (DXH) and FDA review panel - the closest regulatory comparables to K022073.
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K020213 · Rozinn Electronics, Inc. · Apr 2002
TM2000, MODEL 1
K013879 · Card Guard Scientific Survival , Ltd. · Feb 2002
ECG HOME
K012012 · H&C Medical Devices Spa · Jan 2002
K022073 · HEARTLINE RECEIVING STATION
Download PDF FDA Summary Aerotel Medical Syste…