Cleared Traditional

K770264 - PACEGUARD

K770264 is an FDA 510(k) clearance for PACEGUARD, manufactured by Cardio Data. The device is a Class 2 Cardiovascular device with product code DXH cleared through the Traditional 510(k) pathway after a 5-day FDA review.

K770264 · Cardio Data · Cardiovascular device
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Feb 1977
Decision
5d
Days
Class 2
Risk

K770264 is an FDA 510(k) clearance for the PACEGUARD. Classified as Transmitters And Receivers, Electrocardiograph, Telephone (product code DXH), Class II - Special Controls.

Submitted by Cardio Data (Mchenry, US). The FDA issued a Cleared decision on February 16, 1977 after a review of 5 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 Cardio Data devices

FDA 510(k) Submission Details - K770264

510(k) Number K770264 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 1977
Decision Date February 16, 1977
Days to Decision 5 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
120d faster than avg
Panel avg: 125d · This submission: 5d
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 203
Devices cleared under the same product code (DXH) and FDA review panel - the closest regulatory comparables to K770264.
TELETRACE TELEPHONE EKG TRANSMITTER
K780158 · Medtronic Vascular · Mar 1978
PATIENT ALERT MODEL 555
K772350 · Intermedics, Inc. · Mar 1978
ELECTROCARDIOGRAPH TRANSMITTER, 536
K772186 · Intermedics, Inc. · Feb 1978
TR-3 TRANSMITTER
K760857 · Burdick Corp. · Jan 1977
ECG MONITOR (TELEPHONE ECG TRANSMITTER)
K761066 · Physio-Control Corp. · Dec 1976
ECG MODULATOR
K760563 · Physio-Control Corp. · Sep 1976