Cleared Traditional

K812755 - MODEL 535-03 TRACE A PACE

K812755 is an FDA 510(k) clearance for MODEL 535-03 TRACE A PACE, 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 47-day FDA review.

K812755 · Intermedics, Inc. · Cardiovascular device
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Nov 1981
Decision
47d
Days
Class 2
Risk

K812755 is an FDA 510(k) clearance for the MODEL 535-03 TRACE A PACE. 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 November 16, 1981 after a review of 47 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 Intermedics, Inc. devices

FDA 510(k) Submission Details - K812755

510(k) Number K812755 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 1981
Decision Date November 16, 1981
Days to Decision 47 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
78d faster than avg
Panel avg: 125d · This submission: 47d
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 K812755.
SIRECUST 456
K830028 · Analogic Corp. · Jan 1983
MODEL 4242 TELE SYST ARRHYTHMIA MONITOR
K822955 · Medtronic Vascular · Nov 1982
MODEL 535-02 TRACE-A-PACE TRANSMITTER
K821726 · Intermedics, Inc. · Jul 1982
MODEL 9408 A TELETRACE
K812703 · Medtronic Vascular · Oct 1981
MODEL 535-01 TRACE-A-PACE EKG/TELEMETRY
K811464 · Intermedics, Inc. · Sep 1981
TELETRACE TELEPHONE EKG SYSTEM
K811512 · Medtronic Vascular · Jun 1981