Cleared Traditional

K860239 - ORG-7201 MULTIPARAMETER TELEMETRY MONITOR

K860239 is an FDA 510(k) clearance for ORG-7201 MULTIPARAMETER TELEMETRY MONITOR, manufactured by Nihon Kohden America, Inc.. The device is a Class 2 Cardiovascular device with product code DRG cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K860239 · Nihon Kohden America, Inc. · Cardiovascular device
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Jun 1986
Decision
154d
Days
Class 2
Risk

K860239 is an FDA 510(k) clearance for the ORG-7201 MULTIPARAMETER TELEMETRY MONITOR. Classified as Transmitters And Receivers, Physiological Signal, Radiofrequency (product code DRG), Class II - Special Controls.

Submitted by Nihon Kohden America, Inc. (Irvine, US). The FDA issued a Cleared decision on June 26, 1986 after a review of 154 days - an extended review 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: 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 Nihon Kohden America, Inc. devices

FDA 510(k) Submission Details - K860239

510(k) Number K860239 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 1986
Decision Date June 26, 1986
Days to Decision 154 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d slower than avg
Panel avg: 125d · This submission: 154d
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 73
Devices cleared under the same product code (DRG) and FDA review panel - the closest regulatory comparables to K860239.
CARDIOCAP DR-124 RECORDER
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CD TELEMETRY SYSTEMS
K891104 · Marquette Electronics, Inc. · Apr 1989
MODEL 1010 PHYSIOLOGICAL SIGNAL TELEMETRY MONITOR
K873672 · Novametrix Medical Systems, Inc. · Dec 1987
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