Cleared Traditional

P.E.T. (K812793) - FDA 510(k) Clearance

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

K812793 · Hospital Equipment Service · Cardiovascular device
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Jan 1982
Decision
104d
Days
Class 2
Risk

K812793 is an FDA 510(k) clearance for the P.E.T.. Classified as Transmitters And Receivers, Electrocardiograph, Telephone (product code DXH), Class II - Special Controls.

Submitted by Hospital Equipment Service (Mchenry, US). The FDA issued a Cleared decision on January 18, 1982 after a review of 104 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 Hospital Equipment Service devices

Submission Details

510(k) Number K812793 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 1981
Decision Date January 18, 1982
Days to Decision 104 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 125d · This submission: 104d
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 K812793.
PAGE-WRITER INTERPRETIVE CARDIOGRAPH
K842370 · Hewlett-Packard Co. · Dec 1984
MODEL 4242 TELE SYST ARRHYTHMIA MONITOR
K822955 · Medtronic Vascular · Nov 1982
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
MODEL 535-01 TRACE-A-PACE EKG/TELEMETRY
K811464 · Intermedics, Inc. · Sep 1981