Cleared Traditional

BSM-2100A CONFIGURED PATIENT MONITOR (K914092) - FDA 510(k) Clearance

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

K914092 · Nihon Kohden America, Inc. · Cardiovascular device
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May 1992
Decision
259d
Days
Class 2
Risk

K914092 is an FDA 510(k) clearance for the BSM-2100A CONFIGURED PATIENT MONITOR. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Nihon Kohden America, Inc. (Irvine, US). The FDA issued a Cleared decision on May 28, 1992 after a review of 259 days - an extended review cycle.

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

Submission Details

510(k) Number K914092 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 1991
Decision Date May 28, 1992
Days to Decision 259 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
134d slower than avg
Panel avg: 125d · This submission: 259d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DSI Detector And Alarm, Arrhythmia
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 - DSI Detector And Alarm, Arrhythmia

All 98
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K914092.
CC ARHYTHMIS MONITORING OPTION
K923747 · Hewlett-Packard Co. · Jul 1993
BSM-8800A BEDSIDE MONITOR
K920154 · Nihon Kohden America, Inc. · Dec 1992
DUAL LEAD (ECG1 & ECG2) ARRHYTHMIA ANALYSIS
K920743 · Nihon Kohden America, Inc. · Sep 1992
ZB-860PA MULTIPARAMETER TRANSMITTER
K913117 · Nihon Kohden America, Inc. · Apr 1992
ORG-8200A UNIVERSAL SIGNAL HOUSING
K912744 · Nihon Kohden America, Inc. · Dec 1991
HEWLETT-PACKARD MODEL 78720AC ARRHYTHMIA MONIT SYS
K913451 · Hewlett-Packard Co. · Oct 1991