Cleared Special

K023418 - HEARTONE EVENT RECORDER AND TRANSMITTER

K023418 is an FDA 510(k) clearance for HEARTONE EVENT RECORDER AND TRANSMITTER, 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 26-day FDA review.

K023418 · 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
Nov 2002
Decision
26d
Days
Class 2
Risk

K023418 is an FDA 510(k) clearance for the HEARTONE EVENT RECORDER AND TRANSMITTER. 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 November 6, 2002 after a review of 26 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 - K023418

510(k) Number K023418 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 2002
Decision Date November 06, 2002
Days to Decision 26 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
99d faster than avg
Panel avg: 125d · This submission: 26d
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 K023418.
MEDSTAR SYSTEM, MODELS 533-300
K020534 · Cybernet Medical · Feb 2003
CG-500 PMP PERSONAL MEDICAL PHONE SYSTEM
K023689 · Card Guard Scientific Survival , Ltd. · Jan 2003
TM2005 PERSONAL MEDICAL PHONE CENTER
K024365 · Card Guard Scientific Survival , Ltd. · Jan 2003
HEARTLINE RECEIVING STATION
K022073 · Aerotel Medical Systems (1998) , Ltd. · Jul 2002
NETLINK/NETSCAN
K020213 · Rozinn Electronics, Inc. · Apr 2002
TM2000, MODEL 1
K013879 · Card Guard Scientific Survival , Ltd. · Feb 2002
K023418 · HEARTONE EVENT RECORDER AND TRANSMITTER
Download PDF FDA Summary Aerotel Medical Syste…