Cleared Traditional

TELESCAN INSTANT MEMORY ECG RECORDER MODEL T-35CM (K883358) - FDA 510(k) Clearance

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

K883358 · Telescan Medical Systems · Cardiovascular device
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Oct 1988
Decision
65d
Days
Class 2
Risk

K883358 is an FDA 510(k) clearance for the TELESCAN INSTANT MEMORY ECG RECORDER MODEL T-35CM. Classified as Transmitters And Receivers, Electrocardiograph, Telephone (product code DXH), Class II - Special Controls.

Submitted by Telescan Medical Systems (Auburn, US). The FDA issued a Cleared decision on October 13, 1988 after a review of 65 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 Telescan Medical Systems devices

Submission Details

510(k) Number K883358 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 1988
Decision Date October 13, 1988
Days to Decision 65 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 125d · This submission: 65d
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 K883358.
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M1400A TRANSMITTER,M1402 RECEIVER,M1401 MAINFRAME
K894277 · Hewlett-Packard Co. · Sep 1989
MEDTRONIC MODEL 9443 IN-OFFICE TRANSMITTER
K894140 · Medtronic Vascular · Jul 1989
MEDTRONIC MODEL 4220 AMBULATORY ECG MONITOR
K870652 · Medtronic Vascular · May 1987
WEP 7604 TELEMETRY MONITOR
K854369 · Nihon Kohden America, Inc. · Feb 1986
#9431 TELETRACE, TELEPHONE, EKG TRANSMITTER
K852971 · Medtronic Vascular · Oct 1985