Cleared Traditional

TELEMETRY TRANSMITTER & RECEIVER (K813064) - FDA 510(k) Clearance

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

K813064 · Honeywell, Inc. · Cardiovascular device
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Dec 1981
Decision
60d
Days
Class 2
Risk

K813064 is an FDA 510(k) clearance for the TELEMETRY TRANSMITTER & RECEIVER. Classified as Transmitters And Receivers, Physiological Signal, Radiofrequency (product code DRG), Class II - Special Controls.

Submitted by Honeywell, Inc. (Walker, US). The FDA issued a Cleared decision on December 29, 1981 after a review of 60 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2910 - 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 Honeywell, Inc. devices

Submission Details

510(k) Number K813064 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 1981
Decision Date December 29, 1981
Days to Decision 60 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 125d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2910
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 - DRG Transmitters And Receivers, Physiological Signal, Radiofrequency

All 53
Devices cleared under the same product code (DRG) and FDA review panel - the closest regulatory comparables to K813064.
MODEL 78210A TELEMETRY TRANSMITTER
K844376 · Hewlett-Packard Co. · Jan 1985
LIFESCOPE II/FOUR
K823249 · Nihon Kohden America, Inc. · Nov 1982
EXERCISE ECG ELECTRODES, REUSABLE
K821384 · Respironics, Inc. · Jun 1982
DUO-TEL
K810331 · General Electric Co. · Mar 1981
TELEMETRY PACEMAKER MONITOR
K802357 · Intermedics, Inc. · Feb 1981
TELEMETRY TRANSMITTER, #TLT-3
K802273 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1980