Cleared Traditional

TELEMANOMETER (K850166) - FDA 510(k) Clearance

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

K850166 · R.J. Ash, Medical Monitoring, Inc. · Cardiovascular device
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Apr 1985
Decision
92d
Days
Class 2
Risk

K850166 is an FDA 510(k) clearance for the TELEMANOMETER. Classified as Transmitters And Receivers, Physiological Signal, Radiofrequency (product code DRG), Class II - Special Controls.

Submitted by R.J. Ash, Medical Monitoring, Inc. (Pittsburgh, US). The FDA issued a Cleared decision on April 18, 1985 after a review of 92 days - within the typical 510(k) review window.

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: 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 R.J. Ash, Medical Monitoring, Inc. devices

Submission Details

510(k) Number K850166 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 1985
Decision Date April 18, 1985
Days to Decision 92 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 125d · This submission: 92d
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 K850166.
SIEMENS 1481 T TRANSMITTER, ENHANCED
K945037 · Siemens Medical Solutions USA, Inc. · Mar 1995
ORG-7201 MULTIPARAMETER TELEMETRY MONITOR
K860239 · Nihon Kohden America, Inc. · Jun 1986
QUINTON Q-TEL 418T & 419T REMOTE CARDIAC MONITOR
K851302 · Quinton, Inc. · May 1985
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