Cleared Traditional

K872869 - STAND. CLEAR VINYL DISPOSABLE ECG ELECT...

K872869 is the FDA 510(k) clearance for STAND. CLEAR VINYL DISPOSABLE ECG ELECT... by Labeltape Meditect, Inc.. It is a Class 2 Cardiovascular device (product code DXH) cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K872869 · Labeltape Meditect, Inc. · Cardiovascular device
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Nov 1987
Decision
106d
Days
Class 2
Risk

K872869 is an FDA 510(k) clearance for the STAND. CLEAR VINYL DISPOSABLE ECG ELECT.(597 ADHE). Classified as Transmitters And Receivers, Electrocardiograph, Telephone (product code DXH), Class II - Special Controls.

Submitted by Labeltape Meditect, Inc. (Grand Rapids, US). The FDA issued a Cleared decision on November 4, 1987 after a review of 106 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 Labeltape Meditect, Inc. devices

Submission Details

510(k) Number K872869 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 1987
Decision Date November 04, 1987
Days to Decision 106 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 125d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 103
Devices cleared under the same product code (DXH) and FDA review panel - the closest regulatory comparables to K872869.
M1400A TRANSMITTER,M1402 RECEIVER,M1401 MAINFRAME
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K870652 · Medtronic Vascular · May 1987
WEP 7604 TELEMETRY MONITOR
K854369 · Nihon Kohden America, Inc. · Feb 1986
CMS 8000
K853096 · Physio-Control Corp. · Jan 1986