HFM · Monitor, Uterine Contraction, External (For Use In Clinic)
Obstetrics/Gynecology · 21 CFR 884.2720 · Class 2
Overview
| Product Code | HFM |
|---|---|
| Device Name | Monitor, Uterine Contraction, External (For Use In Clinic) |
| Regulation | 21 CFR 884.2720 |
| Device Class | Class 2 |
| Review Panel | Obstetrics/Gynecology |
| 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 | KOALA TOCO | Clinical Innovations, LLC | May 29, 2014 | SESE |
| K061044 | FEATHERLITE AQUA TOCODYNAMOMETER | Ventrex, Inc. | Jul 12, 2006 | SESE |
| K040392 | TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING | American I.V. Products, Inc. | Sep 14, 2004 | SESE |
| K013477 | TOCO LITE, MODEL TD-01 | Ventrex, Inc. | Jan 17, 2002 | SESE |
| K994353 | SECURELINE DISPOSABLE FETAL MONITORING STRAPS #3860 AND #3565 | Precision Dynamics Corp. | Mar 22, 2000 | SESE |
| K992811 | TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING | Epic Medical Equipment Services, Inc. | Jan 18, 2000 | SESE |
| K954847 | DISCO UTERINE CONTRACTION TRANSDUCER & ACCESSORIES | Ocg Systems, Inc. | May 22, 1996 | SESE |
| K952579 | TOCO TRANSDUCER | Scientific Device Manufacturer, LLC | Aug 4, 1995 | SESE |
| K920152 | BUBBLE TOCO | Utah Medical Products, Inc. | May 26, 1993 | SESE |
| K910282 | MEDI-TRACE(R) DISPOSABLE TOCOTONOMETER | Graphic Controls Corp. | Mar 29, 1991 | SESE |
| K904691 | AIR-SHIELDS VICKERS TELESCAN TELECOM DISPLAY SYST | Air-Shields Vickers, Inc. | Feb 19, 1991 | SESE |
| K903623 | MODEL600 UTERINE ACTIVITY MONITOR | Corometrics Medical Systems, Inc. | Nov 7, 1990 | SESE |
| K902104 | ORION WATCHGUARD | Orion Industries | Oct 25, 1990 | SESE |
| P890063 | GENESIS(R) HOME UTERINE ACTIVITY MONITORING SYSTEM | Matria Healthcare, Inc. | Sep 12, 1990 | APRL |
| K894030 | MODEL 37 UTERINE CONTRACTION ACTIVITY MONITOR | Healthdyne, Inc. | Jan 22, 1990 | SESE |
| K893770 | TERM GUARD II DEVICE | Tokos Medical Corp. | Nov 3, 1989 | SESE |
| K891997 | CATALOG #2270AAX, 2270DAX BELTLESS TOCOTRANSDUCER | Corometrics Medical Systems, Inc. | Jun 8, 1989 | SESE |
| K882080 | MODEL NUMBER (TBD) TOCO DATA TELEPHONE TRANS. SYS. | Aequitron Medical, Inc. | Mar 1, 1989 | SESE |
| K874631 | HEALTHPHONE TOCO MODEL | Carelink | Mar 11, 1988 | SESE |
| K873150 | 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
