Cleared Traditional

K896040 - KING OF HEARTS CDM

K896040 is an FDA 510(k) clearance for KING OF HEARTS CDM, 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 211-day FDA review.

K896040 · Instromedix, Inc. · Cardiovascular device
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May 1990
Decision
211d
Days
Class 2
Risk

K896040 is an FDA 510(k) clearance for the KING OF HEARTS CDM. 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 May 15, 1990 after a review of 211 days - an extended review cycle.

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. Standard predicate reliance. 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 - K896040

510(k) Number K896040 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 1989
Decision Date May 15, 1990
Days to Decision 211 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
86d slower than avg
Panel avg: 125d · This submission: 211d
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 113
Devices cleared under the same product code (DXH) and FDA review panel - the closest regulatory comparables to K896040.
PDT CARRYALL TRANSMITTER, VARIOUS MODELS
K912379 · Cardiac Pacemakers, Inc. · Jun 1991
MODEL 9444 TELETRACE II ECG MONITORING SYSTEM
K903960 · Medtronic Vascular · Oct 1990
ESCORT MODEL 400T TELEMETRY ECG MONITOR
K902254 · Medical Data Electronics · Jul 1990
ESCORT-LINK (MODEL E3200)
K901591 · Medical Data Electronics · May 1990
KING OF HEARTS 1200 MONITOR
K896039 · Instromedix, Inc. · Feb 1990
CARRY-ALL EKG TRANSTELEPHONIC TRANSMITTER
K896002 · Instromedix, Inc. · Jan 1990