Cleared Traditional

K944362 - HEARTCARD CARDIAC EVENT MONITOR

K944362 is an FDA 510(k) clearance for HEARTCARD CARDIAC EVENT MONITOR, manufactured by Instromedix, Inc.. The device is a Class 2 Cardiovascular device with product code DXH cleared through the Traditional 510(k) pathway after a 365-day FDA review.

K944362 · Instromedix, Inc. · Cardiovascular device
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Sep 1995
Decision
365d
Days
Class 2
Risk

K944362 is an FDA 510(k) clearance for the HEARTCARD CARDIAC EVENT MONITOR. Classified as Transmitters And Receivers, Electrocardiograph, Telephone (product code DXH), Class II - Special Controls.

Submitted by Instromedix, Inc. (Hillsboro, US). The FDA issued a Cleared decision on September 7, 1995 after a review of 365 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 Instromedix, Inc. devices

FDA 510(k) Submission Details - K944362

510(k) Number K944362 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 1994
Decision Date September 07, 1995
Days to Decision 365 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
240d slower than avg
Panel avg: 125d · This submission: 365d
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 181
Devices cleared under the same product code (DXH) and FDA review panel - the closest regulatory comparables to K944362.
PACEART CARDIOVOICE
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K945476 · Instromedix, Inc. · Nov 1995
CARDIOMAGIC(R) SOFTWARE ENHANCEMENTS
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CG-1000 PERSONAL ECG TRANSMITTER
K935909 · Card Guard Scientific Survival , Ltd. · Apr 1995
CARRYALL ENHANCEMENTS
K943931 · Instromedix, Inc. · Apr 1995
CARD GUARD, MODEL CG-7000D ECG RECORDER/TRANSMITTER
K942704 · Card Guard Scientific Survival , Ltd. · Dec 1994