Product Code: MLD FDA class 2 21 CFR 870.1025

Monitor, St Segment With Alarm

Cardiovascular

The ST Segment Monitor with Alarm is an electrocardiographic monitoring device that continuously analyzes the ECG to detect ST segment deviations and automatically triggers alarms when abnormal values are detected, alerting clinical staff to potential myocardial ischemia or injury in real time. Classified as a Class 2 device under 21 CFR 870.1025 within the Cardiovascular specialty, it requires 510(k) premarket notification. It carries no implant or life-sustaining flags.

View on FDA

510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Research product code MLD in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Ask the Research Assistant See examples

Basic Information

Product Code: MLD
Device Class: FDA class 2
Regulation Number: 870.1025
Medical Specialty: Cardiovascular
Review Panel: CV
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 14 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K101602	VITAL SIGNS MONITOR	Sep 01, 2010	Substantially Equivalent	Criticare Systems, Inc.
K080461	STAR ST AND ARRHYTHMIA SOFTWARE, RELEASE J.0	Mar 13, 2008	Substantially Equivalent	Philips Medical Systems
K022740	DATEX-OHMEDA S/5 COMPACT CRITICAL CARE MONITOR WITH L-CICU02 & L-CICU02A SOFTWARE	Nov 14, 2002	Substantially Equivalent	Datex-Ohmeda
K012837	MODIFICATION TO: DATEX-OHMEDA CARDIOCAP 5 (REV B) AND ACCESSORIES	Sep 14, 2001	Substantially Equivalent	Datex-Ohmeda
K002105	SIEMENS INFINITY SC 6002XL ENHANCED WITH ST SEGMENT ANALYSIS	Dec 05, 2000	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K992323	DATEX-OHMEDA CARDIOCAP 5, F-MX, F-MXG AND ACCESSORIES	Nov 01, 1999	Substantially Equivalent	Datex-Ohmeda, Inc.
K982104	ESCORT-LINK CENTRAL STATION MONITOR MODEL 20500	Nov 25, 1998	Substantially Equivalent	Medical Data Electronics
K974492	SIEMENS SC6000/SC6000P BEDSIDE MONITORING SYSTEM ENHANCED WITH ST SEGMENT ANALYSIS	Feb 26, 1998	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K972121	ACUITY CENTRAL STATION	Nov 07, 1997	Substantially Equivalent	Protocol Systems, Inc.
K953175	AS/3 ESTPR MODULE	Feb 06, 1997	Substantially Equivalent	Datex Division Instrumentarium Corp.
K960272	EAGLE 3000/3100 PATIENT MONITOR	Oct 02, 1996	Substantially Equivalent	Marquette Electronics, Inc.
K960934	HP M1205A OMNICARE COMPONENT MONITOR SYSTEM MODEL 24	Jun 14, 1996	Substantially Equivalent	Hewlett-Packard Co.
K935020	OMNI-TRAC MODIFICATION	Apr 26, 1995	Substantially Equivalent	Invivo Research, Inc.
K920429	MODIFIED MODEL M1403A TELEMETRY MONITORING SYSTEM	Jul 20, 1993	Substantially Equivalent	Hewlett-Packard Co.