Atlas FDA

HFM

23 FDA 510(k) clearances · Product code

126 daysmedian time to decision
230 days90th percentile
23clearances measured

FDA profile

Official device name
Monitor, Uterine Contraction, External (For Use In Clinic)
Device class
Class II (moderate risk)
Regulation
21 CFR 884.2720
Medical specialty
Obstetrics/Gynecology
Flags
Third-party review eligible
Adverse events (MAUDE)
1995: 1 · 1996: 1 · 1997: 1 · 2010: 4 · 2012: 5
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
KOALA TOCO (K140163)Clinical Innovations, LLC2014-05-29
FEATHERLITE AQUA TOCODYNAMOMETER (K061044)Ventrex, Inc.2006-07-12
TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING (K040392)American I.V. Products, Inc.2004-09-14
TOCO LITE, MODEL TD-01 (K013477)Ventrex, Inc.2002-01-17
SECURELINE DISPOSABLE FETAL MONITORING STRAPS #3860 AND #3565 (K994353)Precision Dynamics Corp.2000-03-22
TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING (K992811)Epic Medical Equipment Services, Inc.2000-01-18
DISCO UTERINE CONTRACTION TRANSDUCER & ACCESSORIES (K954847)Ocg Systems, Inc.1996-05-22
TOCO TRANSDUCER (K952579)Scientific Device Manufacturer, LLC1995-08-04
BUBBLE TOCO (K920152)Utah Medical Products, Inc.1993-05-26
MEDI-TRACE(R) DISPOSABLE TOCOTONOMETER (K910282)Graphic Controls Corp.1991-03-29
AIR-SHIELDS VICKERS TELESCAN TELECOM DISPLAY SYST (K904691)Air-Shields Vickers, Inc.1991-02-19
MODEL600 UTERINE ACTIVITY MONITOR (K903623)Corometrics Medical Systems, Inc.1990-11-07
ORION WATCHGUARD (K902104)Orion Industries1990-10-25
MODEL 37 UTERINE CONTRACTION ACTIVITY MONITOR (K894030)Healthdyne, Inc.1990-01-22
TERM GUARD II DEVICE (K893770)Tokos Medical Corp.1989-11-03
CATALOG #2270AAX, 2270DAX BELTLESS TOCOTRANSDUCER (K891997)Corometrics Medical Systems, Inc.1989-06-08
MODEL NUMBER (TBD) TOCO DATA TELEPHONE TRANS. SYS. (K882080)Aequitron Medical, Inc.1989-03-01
PDS, MODEL NST 40 FETAL MONITOR, RECORDER & TRANS. (K873150)Pediatric Diagnostic Service1988-03-11
HEALTHPHONE TOCO MODEL (K874631)Carelink1988-03-11
AIR-CUSHION TOCOTONOMETER (K860933)International Biomedics, Inc.1986-07-09
EXTERNAL UTERINE CONTRACTION MONITOR-TOKODYNAMOMET (K853856)Aequitron Medical, Inc.1986-03-12
TERM GUARD 5000 UTERINE ACTIVITY (K843011)Tokos Medical Corp.1984-11-01
TOCO DATA TELEPHONE TRANSMITTER DT100P (K840747)Advantage Medical Systems, Inc.1984-06-19

Track HFM automatically

Every clearance here is in the API, with alerts when new ones post.