Cleared Traditional

K992323 - DATEX-OHMEDA CARDIOCAP 5

K992323 is an FDA 510(k) clearance for DATEX-OHMEDA CARDIOCAP 5, manufactured by Datex-Ohmeda, Inc.. The device is a Class 2 Cardiovascular device with product code MLD cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K992323 · Datex-Ohmeda, Inc. · Cardiovascular device
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Nov 1999
Decision
112d
Days
Class 2
Risk

K992323 is an FDA 510(k) clearance for the DATEX-OHMEDA CARDIOCAP 5, F-MX, F-MXG AND ACCESSORIES. Classified as Monitor, St Segment With Alarm (product code MLD), Class II - Special Controls.

Submitted by Datex-Ohmeda, Inc. (Tewksburt, US). The FDA issued a Cleared decision on November 1, 1999 after a review of 112 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 Datex-Ohmeda, Inc. devices

FDA 510(k) Submission Details - K992323

510(k) Number K992323 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 1999
Decision Date November 01, 1999
Days to Decision 112 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
13d faster than avg
Panel avg: 125d · This submission: 112d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MLD Device Classification - Class 2, Special Controls

Product Code MLD Monitor, St Segment With Alarm
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 - MLD Monitor, St Segment With Alarm

All 10
Devices cleared under the same product code (MLD) and FDA review panel - the closest regulatory comparables to K992323.
DATEX-OHMEDA S/5 COMPACT CRITICAL CARE MONITOR WITH L-CICU02 & L-CICU02A SOFTWARE
K022740 · Datex-Ohmeda · Nov 2002
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K012837 · Datex-Ohmeda · Sep 2001
SIEMENS INFINITY SC 6002XL ENHANCED WITH ST SEGMENT ANALYSIS
K002105 · Siemens Medical Solutions USA, Inc. · Dec 2000
ESCORT-LINK CENTRAL STATION MONITOR MODEL 20500
K982104 · Medical Data Electronics · Nov 1998
SIEMENS SC6000/SC6000P BEDSIDE MONITORING SYSTEM ENHANCED WITH ST SEGMENT ANALYSIS
K974492 · Siemens Medical Solutions USA, Inc. · Feb 1998
AS/3 ESTPR MODULE
K953175 · Datex Division Instrumentarium Corp. · Feb 1997