Cleared Traditional

K841501 - LIFESCOPE 6 OEC-6102

K841501 is an FDA 510(k) clearance for LIFESCOPE 6 OEC-6102, manufactured by Nihon Kohden America, Inc.. The device is a Class 2 Cardiovascular device with product code DRT cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K841501 · Nihon Kohden America, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1984
Decision
140d
Days
Class 2
Risk

K841501 is an FDA 510(k) clearance for the LIFESCOPE 6 OEC-6102. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Nihon Kohden America, Inc. (Foothill, US). The FDA issued a Cleared decision on August 28, 1984 after a review of 140 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - 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 - K841501

510(k) Number K841501 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 1984
Decision Date August 28, 1984
Days to Decision 140 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
15d slower than avg
Panel avg: 125d · This submission: 140d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRT Device Classification - Class 2, Special Controls

Product Code DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2300
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 - DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)

All 167
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K841501.
HEART RATE/RESPIRATION SIMULATOR 8310
K841363 · Aequitron Medical, Inc. · Oct 1984
SERVOMED OXCARDIORE SPIROGRAPH 324/111
K840832 · Litton Medical Electronics · Sep 1984
LIFESCOPE II
K841499 · Nihon Kohden America, Inc. · Aug 1984
LIFESCOPE 6 OEC-6105
K841502 · Nihon Kohden America, Inc. · Aug 1984
DYNASCOPE SERIES
K840055 · Fukuda Denshi USA, Inc. · Aug 1984
AIR SHIELDS AS461 MONITORING SYS
K842321 · Air-Shields, Inc. · Aug 1984