Cleared Traditional

ANESTHESIA MONITOR (K030105) - FDA 510(k) Clearance

Also marketed or referenced as:
BEDSIDE MONITOR, SERIES BSM-5130A

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

K030105 · Nihon Kohden America, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2003
Decision
50d
Days
Class 2
Risk

K030105 is an FDA 510(k) clearance for the ANESTHESIA MONITOR. Classified as Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (product code MHX), Class II - Special Controls.

Submitted by Nihon Kohden America, Inc. (Foothill, US). The FDA issued a Cleared decision on March 4, 2003 after a review of 50 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Nihon Kohden America, Inc. devices

Submission Details

510(k) Number K030105 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 2003
Decision Date March 04, 2003
Days to Decision 50 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
75d faster than avg
Panel avg: 125d · This submission: 50d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 160
Devices cleared under the same product code (MHX) and FDA review panel - the closest regulatory comparables to K030105.
DINAMAP PRO 1000 MONITOR WITH SUPERSTAT, MODEL 1000
K022834 · Ge Medical Systems Information Technologies · May 2003
EK-PRO ARRHYTHMIA DETECTION ALGORITHM
K031320 · Ge Medical Systems Information Technologies · May 2003
MODIFICATION TO SOLAR 9500 INFORMATION MONITOR
K030575 · Ge Medical Systems Information Technologies · Mar 2003
MODIFICATION TO DASH 3000/4000 PATIENT MONITOR
K030431 · Ge Medical Systems Information Technologies · Feb 2003
SIEMENS INFINITY SC 6002XL MODIFICATIONS
K030313 · Siemens Medical Solutions USA, Inc. · Feb 2003
SIEMENS MULTI VIEW INFINITY TELEMETRY SYSTEM
K024108 · Siemens Medical Solutions USA, Inc. · Dec 2002