Cleared Traditional

AS/3 ANESTHESIA MONTIOR WITH S-ANE99(A)/L-ARK99(A) (K000815) - FDA 510(k) Clearance

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

K000815 · Datex-Ohmeda · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2000
Decision
87d
Days
Class 2
Risk

K000815 is an FDA 510(k) clearance for the AS/3 ANESTHESIA MONTIOR WITH S-ANE99(A)/L-ARK99(A). Classified as Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (product code MHX), Class II - Special Controls.

Submitted by Datex-Ohmeda (Tewksbury, US). The FDA issued a Cleared decision on June 8, 2000 after a review of 87 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 Datex-Ohmeda devices

Submission Details

510(k) Number K000815 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 2000
Decision Date June 08, 2000
Days to Decision 87 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 125d · This submission: 87d
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 161
Devices cleared under the same product code (MHX) and FDA review panel - the closest regulatory comparables to K000815.
CNS-9300 SERIES CENTRAL STATION
K001433 · Nihon Kohden America, Inc. · Nov 2000
LIFE SCOPE P, MODEL BSM-4100 SERIES
K001693 · Nihon Kohden America, Inc. · Oct 2000
LIFE SCOPE EC, MODEL BSM-1102
K000517 · Nihon Kohden America, Inc. · Aug 2000
SIEMENS INFINITY SC 6002XL PORTABLE PATIENT MONITOR
K993974 · Siemens Medical Solutions USA, Inc. · Feb 2000
SIEMENS SC 8000 BEDSIDE MONITOR WITH ADVANCED COMMUNICATION OPTION
K990563 · Siemens Medical Solutions USA, Inc. · Mar 1999
PORTABLE PATIENT MONITOR
K945134 · Hewlett-Packard Co. · Oct 1994