Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart B — Cardiovascular Diagnostic Devices](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices) → [21 CFR 870.1025](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1025) → MLD — Monitor, St Segment With Alarm

# MLD · Monitor, St Segment With Alarm

_Cardiovascular · 21 CFR 870.1025 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MLD

## Overview

- **Product Code:** MLD
- **Device Name:** Monitor, St Segment With Alarm
- **Regulation:** [21 CFR 870.1025](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1025)
- **Device Class:** 2
- **Review Panel:** [Cardiovascular](/submissions/CV)

## Identification

The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.

## Classification Rationale

Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.

## Special Controls

*Classification.* Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.

## Recent Cleared Devices (14 of 14)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K101602](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MLD/K101602.md) | VITAL SIGNS MONITOR | Criticare Systems, Inc. | Sep 1, 2010 | SESE |
| [K080461](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MLD/K080461.md) | STAR ST AND ARRHYTHMIA SOFTWARE, RELEASE J.0 | Philips Medical Systems | Mar 13, 2008 | SESE |
| [K022740](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MLD/K022740.md) | DATEX-OHMEDA S/5 COMPACT CRITICAL CARE MONITOR WITH L-CICU02 & L-CICU02A SOFTWARE | Datex-Ohmeda | Nov 14, 2002 | SESE |
| [K012837](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MLD/K012837.md) | MODIFICATION TO: DATEX-OHMEDA CARDIOCAP 5 (REV B) AND ACCESSORIES | Datex-Ohmeda | Sep 14, 2001 | SESE |
| [K002105](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MLD/K002105.md) | SIEMENS INFINITY SC 6002XL ENHANCED WITH ST SEGMENT ANALYSIS | Siemens Medical Solutions USA, Inc. | Dec 5, 2000 | SESE |
| [K992323](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MLD/K992323.md) | DATEX-OHMEDA CARDIOCAP 5, F-MX, F-MXG AND ACCESSORIES | Datex-Ohmeda, Inc. | Nov 1, 1999 | SESE |
| [K982104](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MLD/K982104.md) | ESCORT-LINK CENTRAL STATION MONITOR MODEL 20500 | Medical Data Electronics | Nov 25, 1998 | SESE |
| [K974492](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MLD/K974492.md) | SIEMENS SC6000/SC6000P BEDSIDE MONITORING SYSTEM ENHANCED WITH ST SEGMENT ANALYSIS | Siemens Medical Solutions USA, Inc. | Feb 26, 1998 | SESE |
| [K972121](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MLD/K972121.md) | ACUITY CENTRAL STATION | Protocol Systems, Inc. | Nov 7, 1997 | SESE |
| [K953175](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MLD/K953175.md) | AS/3 ESTPR MODULE | Datex Division Instrumentarium Corp. | Feb 6, 1997 | SESE |
| [K960272](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MLD/K960272.md) | EAGLE 3000/3100 PATIENT MONITOR | Marquette Electronics, Inc. | Oct 2, 1996 | SESE |
| [K960934](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MLD/K960934.md) | HP M1205A OMNICARE COMPONENT MONITOR SYSTEM MODEL 24 | Hewlett-Packard Co. | Jun 14, 1996 | SESE |
| [K935020](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MLD/K935020.md) | OMNI-TRAC MODIFICATION | Invivo Research, Inc. | Apr 26, 1995 | SESE |
| [K920429](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MLD/K920429.md) | MODIFIED MODEL M1403A TELEMETRY MONITORING SYSTEM | Hewlett-Packard Co. | Jul 20, 1993 | SESE |

## Top Applicants

- Datex-Ohmeda — 2 clearances
- Hewlett-Packard Co. — 2 clearances
- Siemens Medical Solutions USA, Inc. — 2 clearances
- Criticare Systems, Inc. — 1 clearance
- Datex Division Instrumentarium Corp. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MLD](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MLD)

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