Cleared Traditional

K001693 - LIFE SCOPE P

K001693 is an FDA 510(k) clearance for LIFE SCOPE P, manufactured by Nihon Kohden America, Inc.. The device is a Class 2 Cardiovascular device with product code MHX cleared through the Traditional 510(k) pathway after a 144-day FDA review.

K001693 · Nihon Kohden America, Inc. · Cardiovascular device
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Oct 2000
Decision
144d
Days
Class 2
Risk

K001693 is an FDA 510(k) clearance for the LIFE SCOPE P, MODEL BSM-4100 SERIES. Classified as Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (product code MHX), Class II - Special Controls.

Submitted by Nihon Kohden America, Inc. (Irvine, US). The FDA issued a Cleared decision on October 24, 2000 after a review of 144 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1025 - 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 - K001693

510(k) Number K001693 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2000
Decision Date October 24, 2000
Days to Decision 144 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
19d slower than avg
Panel avg: 125d · This submission: 144d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MHX Device Classification - Class 2, Special Controls

Product Code MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1025
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 - MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)

All 319
Devices cleared under the same product code (MHX) and FDA review panel - the closest regulatory comparables to K001693.
SIEMENS MEDICAL INFORMATION BUS (MIB) PROTOCOL CONVERTER
K003248 · Siemens Medical Solutions USA, Inc. · Dec 2000
ST/AR ST AND ARRHYTHMIA SOFTWARE, MODEL RELEASE D.0
K003621 · Agilent Technologies, Inc. · Dec 2000
CNS-9300 SERIES CENTRAL STATION
K001433 · Nihon Kohden America, Inc. · Nov 2000
S/5 COMPACT ANESTHESIA MONITOR WITH S-00A05, S-00A06. L-00A07, L00A08
K002478 · Datex-Ohmeda, Inc. · Oct 2000
S/5 COMPACT CRITICAL CARE MONITOR WITH S-00C03 OR S-00C04 SOFTWARE
K002158 · Datex-Ohmeda, Inc. · Sep 2000
LIFE SCOPE EC, MODEL BSM-1102
K000517 · Nihon Kohden America, Inc. · Aug 2000