Cleared Traditional

K850166 - TELEMANOMETER

K850166 is an FDA 510(k) clearance for TELEMANOMETER, manufactured by R.J. Ash, Medical Monitoring, Inc.. The device is a Class 2 Cardiovascular device with product code DRG cleared through the Traditional 510(k) pathway after a 92-day FDA review.

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

FDA 510(k) Submission Details - K850166

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.

DRG Device Classification - Class 2, Special Controls

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 175
Devices cleared under the same product code (DRG) and FDA review panel - the closest regulatory comparables to K850166.
MODEL 1010 PHYSIOLOGICAL SIGNAL TELEMETRY MONITOR
K873672 · Novametrix Medical Systems, Inc. · Dec 1987
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
TELEMETRY SYS SERIES 7700 ECG
K832817 · Marquette Electronics, Inc. · Jan 1984
LIFESCOPE II/FOUR
K823249 · Nihon Kohden America, Inc. · Nov 1982