Browse hierarchy: [Obstetrics/Gynecology (OB)](/submissions/OB) → [Subpart C — Obstetrical and Gynecological Monitoring Devices](/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices) → [21 CFR 884.2720](/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/884.2720) → HFM — Monitor, Uterine Contraction, External (For Use In Clinic) # HFM · Monitor, Uterine Contraction, External (For Use In Clinic) _Obstetrics/Gynecology · 21 CFR 884.2720 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/HFM ## Overview - **Product Code:** HFM - **Device Name:** Monitor, Uterine Contraction, External (For Use In Clinic) - **Regulation:** [21 CFR 884.2720](/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/884.2720) - **Device Class:** 2 - **Review Panel:** [Obstetrics/Gynecology](/submissions/OB) - **3rd-party reviewable:** yes ## Identification An external uterine contraction monitor (i.e., the tokodynamometer) is a device used to monitor the progress of labor. It measures the duration, frequency, and relative pressure of uterine contractions with a transducer strapped to the maternal abdomen. This generic type of device may include an external pressure transducer, support straps, and other patient and equipment supports. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 24) Showing 20 most recent of 24 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K140163](https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/HFM/K140163.md) | KOALA TOCO | Clinical Innovations, LLC | May 29, 2014 | SESE | | [K061044](https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/HFM/K061044.md) | FEATHERLITE AQUA TOCODYNAMOMETER | Ventrex, Inc. | Jul 12, 2006 | SESE | | [K040392](https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/HFM/K040392.md) | TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING | American I.V. Products, Inc. | Sep 14, 2004 | SESE | | [K013477](https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/HFM/K013477.md) | TOCO LITE, MODEL TD-01 | Ventrex, Inc. | Jan 17, 2002 | SESE | | [K994353](https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/HFM/K994353.md) | SECURELINE DISPOSABLE FETAL MONITORING STRAPS #3860 AND #3565 | Precision Dynamics Corp. | Mar 22, 2000 | SESE | | [K992811](https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/HFM/K992811.md) | TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING | Epic Medical Equipment Services, Inc. | Jan 18, 2000 | SESE | | [K954847](https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/HFM/K954847.md) | DISCO UTERINE CONTRACTION TRANSDUCER & ACCESSORIES | Ocg Systems, Inc. | May 22, 1996 | SESE | | [K952579](https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/HFM/K952579.md) | TOCO TRANSDUCER | Scientific Device Manufacturer, LLC | Aug 4, 1995 | SESE | | [K920152](https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/HFM/K920152.md) | BUBBLE TOCO | Utah Medical Products, Inc. | May 26, 1993 | SESE | | [K910282](https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/HFM/K910282.md) | MEDI-TRACE(R) DISPOSABLE TOCOTONOMETER | Graphic Controls Corp. | Mar 29, 1991 | SESE | | [K904691](https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/HFM/K904691.md) | AIR-SHIELDS VICKERS TELESCAN TELECOM DISPLAY SYST | Air-Shields Vickers, Inc. | Feb 19, 1991 | SESE | | [K903623](https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/HFM/K903623.md) | MODEL600 UTERINE ACTIVITY MONITOR | Corometrics Medical Systems, Inc. | Nov 7, 1990 | SESE | | [K902104](https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/HFM/K902104.md) | ORION WATCHGUARD | Orion Industries | Oct 25, 1990 | SESE | | [P890063](https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/HFM/P890063.md) | GENESIS(R) HOME UTERINE ACTIVITY MONITORING SYSTEM | Matria Healthcare, Inc. | Sep 12, 1990 | APRL | | [K894030](https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/HFM/K894030.md) | MODEL 37 UTERINE CONTRACTION ACTIVITY MONITOR | Healthdyne, Inc. | Jan 22, 1990 | SESE | | [K893770](https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/HFM/K893770.md) | TERM GUARD II DEVICE | Tokos Medical Corp. | Nov 3, 1989 | SESE | | [K891997](https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/HFM/K891997.md) | CATALOG #2270AAX, 2270DAX BELTLESS TOCOTRANSDUCER | Corometrics Medical Systems, Inc. | Jun 8, 1989 | SESE | | [K882080](https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/HFM/K882080.md) | MODEL NUMBER (TBD) TOCO DATA TELEPHONE TRANS. SYS. | Aequitron Medical, Inc. | Mar 1, 1989 | SESE | | [K874631](https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/HFM/K874631.md) | HEALTHPHONE TOCO MODEL | Carelink | Mar 11, 1988 | SESE | | [K873150](https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/HFM/K873150.md) | PDS, MODEL NST 40 FETAL MONITOR, RECORDER & TRANS. | Pediatric Diagnostic Service | Mar 11, 1988 | SESE | ## Top Applicants - Aequitron Medical, Inc. — 2 clearances - Corometrics Medical Systems, Inc. — 2 clearances - Tokos Medical Corp. — 2 clearances - Ventrex, Inc. — 2 clearances - Advantage Medical Systems, Inc. — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/HFM](https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/HFM) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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