Cleared Traditional

K844966 - CARDIOBEEPER PROFILE MONITOR

K844966 is an FDA 510(k) clearance for CARDIOBEEPER PROFILE MONITOR, manufactured by Survival Technology, Inc.. The device is a Class 2 Cardiovascular device with product code DXH cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K844966 · Survival Technology, Inc. · Cardiovascular device
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Feb 1985
Decision
46d
Days
Class 2
Risk

K844966 is an FDA 510(k) clearance for the CARDIOBEEPER PROFILE MONITOR. 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 February 8, 1985 after a review of 46 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Survival Technology, Inc. devices

FDA 510(k) Submission Details - K844966

510(k) Number K844966 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 1984
Decision Date February 08, 1985
Days to Decision 46 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 125d · This submission: 46d
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 196
Devices cleared under the same product code (DXH) and FDA review panel - the closest regulatory comparables to K844966.
R-1000 ECG RECEIVER
K851123 · Brentwood Instruments, Inc. · May 1985
T-1000 ECG TRANSMITTER
K851124 · Brentwood Instruments, Inc. · May 1985
MDE ESCORT 1000 & MDE ESCOR 2000
K842716 · Medical Data Electronics · Feb 1985
PAGE-WRITER INTERPRETIVE CARDIOGRAPH
K842370 · Hewlett-Packard Co. · Dec 1984
INSTANT REPLAY
K840587 · Instromedix, Inc. · Oct 1984
MODEM ACCESSORY FOR EPI CARDIA SYS
K834034 · Medicomp, Inc. · May 1984