Cleared Traditional

K896002 - CARRY-ALL EKG TRANSTELEPHONIC TRANSMITTER

K896002 is an FDA 510(k) clearance for CARRY-ALL EKG TRANSTELEPHONIC TRANSMITTER, 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 98-day FDA review.

K896002 · Instromedix, Inc. · Cardiovascular device
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Jan 1990
Decision
98d
Days
Class 2
Risk

K896002 is an FDA 510(k) clearance for the CARRY-ALL EKG TRANSTELEPHONIC TRANSMITTER. 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 January 19, 1990 after a review of 98 days - within the typical 510(k) review window.

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 - K896002

510(k) Number K896002 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 1989
Decision Date January 19, 1990
Days to Decision 98 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
27d faster than avg
Panel avg: 125d · This submission: 98d
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 K896002.
KING OF HEARTS CDM
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K894540 · Physio-Control Corp. · Oct 1989
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K893471 · Medtronic Vascular · Sep 1989
M1400A TRANSMITTER,M1402 RECEIVER,M1401 MAINFRAME
K894277 · Hewlett-Packard Co. · Sep 1989