Cleared Traditional

BSM-8800A BEDSIDE MONITOR (K944422) - FDA 510(k) Clearance

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

K944422 · Nihon Kohden America, Inc. · Cardiovascular device
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May 1995
Decision
281d
Days
Class 2
Risk

K944422 is an FDA 510(k) clearance for the BSM-8800A BEDSIDE 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 24, 1995 after a review of 281 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 K944422 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 1994
Decision Date May 24, 1995
Days to Decision 281 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
156d slower than avg
Panel avg: 125d · This submission: 281d
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 K944422.
HP M1205A OMNICARE COMPONENT TRANSPORT MONITORING SYSTEM MODEL 24
K950821 · Hewlett-Packard Co. · Oct 1995
SIEMENS SC 9000 BEDSIDE MONITOR, SC 9015 BEDSIDE MOINTORING SYSTEM
K946306 · Siemens Medical Solutions USA, Inc. · Jun 1995
NIHON KOHDEN CENTRAL NURSE STATION, CNS-8310A/CNS-8350A
K935877 · Nihon Kohden America, Inc. · May 1995
1481 T DIGITAL TELEMETRY SYSTEMS, ENHANCED
K945384 · Siemens Medical Solutions USA, Inc. · May 1995
SIEMENS SIRECUST 700 BEDSIDE MONITOR MODIFICATIONS
K933177 · Siemens Medical Solutions USA, Inc. · Apr 1995
SC 6000/ SC 6000P/ R50
K944350 · Siemens Medical Solutions USA, Inc. · Apr 1995