Cleared Traditional

K811464 - MODEL 535-01 TRACE-A-PACE EKG/TELEMETRY

K811464 is an FDA 510(k) clearance for MODEL 535-01 TRACE-A-PACE EKG/TELEMETRY, manufactured by Intermedics, Inc.. The device is a Class 2 Cardiovascular device with product code DXH cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K811464 · Intermedics, Inc. · Cardiovascular device
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Sep 1981
Decision
120d
Days
Class 2
Risk

K811464 is an FDA 510(k) clearance for the MODEL 535-01 TRACE-A-PACE EKG/TELEMETRY. Classified as Transmitters And Receivers, Electrocardiograph, Telephone (product code DXH), Class II - Special Controls.

Submitted by Intermedics, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 23, 1981 after a review of 120 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 Intermedics, Inc. devices

FDA 510(k) Submission Details - K811464

510(k) Number K811464 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 1981
Decision Date September 23, 1981
Days to Decision 120 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
5d faster than avg
Panel avg: 125d · This submission: 120d
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 116
Devices cleared under the same product code (DXH) and FDA review panel - the closest regulatory comparables to K811464.
MODEL 535-02 TRACE-A-PACE TRANSMITTER
K821726 · Intermedics, Inc. · Jul 1982
MODEL 535-03 TRACE A PACE
K812755 · Intermedics, Inc. · Nov 1981
MODEL 9408 A TELETRACE
K812703 · Medtronic Vascular · Oct 1981
TELETRACE TELEPHONE EKG SYSTEM
K811512 · Medtronic Vascular · Jun 1981
HP MODEL 4710A ECG TRANSMITTER
K802717 · Hewlett-Packard Co. · Jan 1981
CARDIOTRAK
K802089 · Cardiac Pacemakers, Inc. · Sep 1980