Product Code: HFM FDA class 2 21 CFR 884.2720

Monitor, Uterine Contraction, External (For Use In Clinic)

Obstetrics/Gynecology

The External Uterine Contraction Monitor (for clinical use) is a device placed on the maternal abdomen to non-invasively detect and record the frequency, duration, and relative intensity of uterine contractions during labor, supporting clinical management of labor progress and fetal wellbeing. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is HFM, regulated under 21 CFR 884.2720, within the Obstetrics/Gynecology specialty. It is eligible for third-party 510(k) review.

View on FDA

510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Research product code HFM 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: HFM
Device Class: FDA class 2
Regulation Number: 884.2720
Medical Specialty: Obstetrics/Gynecology
Review Panel: OB
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 23 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K140163	KOALA TOCO	May 29, 2014	Substantially Equivalent	Clinical Innovations, LLC
K061044	FEATHERLITE AQUA TOCODYNAMOMETER	Jul 12, 2006	Substantially Equivalent	Ventrex, Inc.
K040392	TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING	Sep 14, 2004	Substantially Equivalent	American I.V. Products, Inc.
K013477	TOCO LITE, MODEL TD-01	Jan 17, 2002	Substantially Equivalent	Ventrex, Inc.
K994353	SECURELINE DISPOSABLE FETAL MONITORING STRAPS #3860 AND #3565	Mar 22, 2000	Substantially Equivalent	Precision Dynamics Corp.
K992811	TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING	Jan 18, 2000	Substantially Equivalent	Epic Medical Equipment Services, Inc.
K954847	DISCO UTERINE CONTRACTION TRANSDUCER & ACCESSORIES	May 22, 1996	Substantially Equivalent	Ocg Systems, Inc.
K952579	TOCO TRANSDUCER	Aug 04, 1995	Substantially Equivalent	Scientific Device Manufacturer, LLC
K920152	BUBBLE TOCO	May 26, 1993	Substantially Equivalent	Utah Medical Products, Inc.
K910282	MEDI-TRACE(R) DISPOSABLE TOCOTONOMETER	Mar 29, 1991	Substantially Equivalent	Graphic Controls Corp.
K904691	AIR-SHIELDS VICKERS TELESCAN TELECOM DISPLAY SYST	Feb 19, 1991	Substantially Equivalent	Air-Shields Vickers, Inc.
K903623	MODEL600 UTERINE ACTIVITY MONITOR	Nov 07, 1990	Substantially Equivalent	Corometrics Medical Systems, Inc.
K902104	ORION WATCHGUARD	Oct 25, 1990	Substantially Equivalent	Orion Industries
K894030	MODEL 37 UTERINE CONTRACTION ACTIVITY MONITOR	Jan 22, 1990	Substantially Equivalent	Healthdyne, Inc.
K893770	TERM GUARD II DEVICE	Nov 03, 1989	Substantially Equivalent	Tokos Medical Corp.
K891997	CATALOG #2270AAX, 2270DAX BELTLESS TOCOTRANSDUCER	Jun 08, 1989	Substantially Equivalent	Corometrics Medical Systems, Inc.
K882080	MODEL NUMBER (TBD) TOCO DATA TELEPHONE TRANS. SYS.	Mar 01, 1989	Substantially Equivalent	Aequitron Medical, Inc.
K874631	HEALTHPHONE TOCO MODEL	Mar 11, 1988	Substantially Equivalent	Carelink
K873150	PDS, MODEL NST 40 FETAL MONITOR, RECORDER & TRANS.	Mar 11, 1988	Substantially Equivalent	Pediatric Diagnostic Service
K860933	AIR-CUSHION TOCOTONOMETER	Jul 09, 1986	Substantially Equivalent	International Biomedics, Inc.
K853856	EXTERNAL UTERINE CONTRACTION MONITOR-TOKODYNAMOMET	Mar 12, 1986	Substantially Equivalent	Aequitron Medical, Inc.
K843011	TERM GUARD 5000 UTERINE ACTIVITY	Nov 01, 1984	Substantially Equivalent	Tokos Medical Corp.
K840747	TOCO DATA TELEPHONE TRANSMITTER DT100P	Jun 19, 1984	Substantially Equivalent	Advantage Medical Systems, Inc.