Cleared Traditional

CARDIOBEEPER(R) III (K880300) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K880300 · Survival Technology, Inc. · Cardiovascular device
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May 1988
Decision
108d
Days
Class 2
Risk

K880300 is an FDA 510(k) clearance for the CARDIOBEEPER(R) III. Classified as Transmitters And Receivers, Electrocardiograph, Telephone (product code DXH), Class II - Special Controls.

Submitted by Survival Technology, Inc. (Bethesda, US). The FDA issued a Cleared decision on May 12, 1988 after a review of 108 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 Survival Technology, Inc. devices

Submission Details

510(k) Number K880300 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 1988
Decision Date May 12, 1988
Days to Decision 108 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 125d · This submission: 108d
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 54
Devices cleared under the same product code (DXH) and FDA review panel - the closest regulatory comparables to K880300.
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MEDTRONIC MODEL 9443 IN-OFFICE TRANSMITTER
K894140 · Medtronic Vascular · Jul 1989
MEDTRONIC MODEL 4220 AMBULATORY ECG MONITOR
K870652 · Medtronic Vascular · May 1987
WEP 7604 TELEMETRY MONITOR
K854369 · Nihon Kohden America, Inc. · Feb 1986
#9431 TELETRACE, TELEPHONE, EKG TRANSMITTER
K852971 · Medtronic Vascular · Oct 1985