Cleared Traditional

K953762 - HEART 400 ECG TRANSMITTER

K953762 is an FDA 510(k) clearance for HEART 400 ECG TRANSMITTER, 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 342-day FDA review.

K953762 · Aerotel, Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1996
Decision
342d
Days
Class 2
Risk

K953762 is an FDA 510(k) clearance for the HEART 400 ECG TRANSMITTER. 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 July 18, 1996 after a review of 342 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 Aerotel, Ltd. devices

FDA 510(k) Submission Details - K953762

510(k) Number K953762 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 1995
Decision Date July 18, 1996
Days to Decision 342 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
217d slower than avg
Panel avg: 125d · This submission: 342d
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 136
Devices cleared under the same product code (DXH) and FDA review panel - the closest regulatory comparables to K953762.
HEART AIDE MULTPLE/HEART AIDE PLUS/HEART AIDE PLUS II
K964888 · Tz Medical, Inc. · Feb 1997
CARD GUARD MODEL CG-6106 PERSONAL ELECTROCARDIOGRAM (ECG) TRANSMITTER DEVICE
K963811 · Card Guard Scientific Survival , Ltd. · Dec 1996
CARD GUARD MODEL CG-6500
K954350 · Card Guard Scientific Survival , Ltd. · Sep 1996
ACCELERATED TRANSMISSION PROTOCOL
K955060 · Instromedix, Inc. · Apr 1996
LIFESIGNS RECEIVING CENER 2000 TRANSTELEPHONIC RECEIVER
K951096 · Instromedix, Inc. · Jan 1996
HEARTHWATCH III(TM)
K945476 · Instromedix, Inc. · Nov 1995