Cleared Special

K012837 - MODIFICATION TO: DATEX-OHMEDA CARDIOCAP...

K012837 is an FDA 510(k) clearance for MODIFICATION TO: DATEX-OHMEDA CARDIOCAP..., manufactured by Datex-Ohmeda. The device is a Class 2 Cardiovascular device with product code MLD cleared through the Special 510(k) pathway after a 22-day FDA review.

K012837 · Datex-Ohmeda · Cardiovascular device
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Sep 2001
Decision
22d
Days
Class 2
Risk

K012837 is an FDA 510(k) clearance for the MODIFICATION TO: DATEX-OHMEDA CARDIOCAP 5 (REV B) AND ACCESSORIES. Classified as Monitor, St Segment With Alarm (product code MLD), Class II - Special Controls.

Submitted by Datex-Ohmeda (Needham, US). The FDA issued a Cleared decision on September 14, 2001 after a review of 22 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Datex-Ohmeda devices

FDA 510(k) Submission Details - K012837

510(k) Number K012837 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 2001
Decision Date September 14, 2001
Days to Decision 22 days
Submission Type Special
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
103d faster than avg
Panel avg: 125d · This submission: 22d
Pathway characteristics
Modification to existing cleared device.

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 K012837.
STAR ST AND ARRHYTHMIA SOFTWARE, RELEASE J.0
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K002105 · Siemens Medical Solutions USA, Inc. · Dec 2000
DATEX-OHMEDA CARDIOCAP 5, F-MX, F-MXG AND ACCESSORIES
K992323 · Datex-Ohmeda, Inc. · Nov 1999
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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