Cleared Traditional

ACCU-CHEK TRANS-TELEPHONIC PACEMAKER TR (K811758) - FDA 510(k) Clearance

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

K811758 · Powers Medical Systmes · Cardiovascular device
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Aug 1981
Decision
42d
Days
Class 2
Risk

K811758 is an FDA 510(k) clearance for the ACCU-CHEK TRANS-TELEPHONIC PACEMAKER TR. Classified as Transmitters And Receivers, Electrocardiograph, Telephone (product code DXH), Class II - Special Controls.

Submitted by Powers Medical Systmes (Walker, US). The FDA issued a Cleared decision on August 3, 1981 after a review of 42 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 Powers Medical Systmes devices

Submission Details

510(k) Number K811758 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 1981
Decision Date August 03, 1981
Days to Decision 42 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 125d · This submission: 42d
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 53
Devices cleared under the same product code (DXH) and FDA review panel - the closest regulatory comparables to K811758.
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
TELETRACE TELEPHONE EKG SYSTEM
K811512 · Medtronic Vascular · Jun 1981
HP MODEL 4710A ECG TRANSMITTER
K802717 · Hewlett-Packard Co. · Jan 1981
UNI-RECORD I
K801700 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1980