Koala Toco
FDA 510(k) K140163 · Clinical Innovations, LLC
510(k) numberK140163
Submission
- Device name
- Koala Toco
- Applicant
- Clinical Innovations, LLC
Marlborough, MA, US - Received
- January 22, 2014
- Decision date
- May 29, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HFM – Monitor, Uterine Contraction, External (For Use In Clinic)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.2720
- Specialty
- Obstetrics/Gynecology
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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K061044 | Featherlite Aqua TocodynamometerHFM · Traditional | Ventrex, Inc. | 07/12/2006SE |
| K040392 | Transducers for Ultrasound and Tocodynamometer Fetal MonitoringHFM · Traditional | American I.V. Products, Inc. | 09/14/2004SE |
| K013477 | Toco Lite, Model TD-01HFM · Traditional | Ventrex, Inc. | 01/17/2002SE |
| K994353 | Secureline Disposable Fetal Monitoring Straps #3860 and #3565HFM · Traditional | Precision Dynamics Corp. | 03/22/2000SE |
| K992811 | Transducers for Ultrasound and Tocodynamometer Fetal MonitoringHFM · Abbreviated | Epic Medical Equipment Services, Inc. | 01/18/2000SE |
| K954847 | Disco Uterine Contraction Transducer & AccessoriesHFM · Traditional | Ocg Systems, Inc. | 05/22/1996SE |
| K952579 | Toco TransducerHFM · Traditional | Scientific Device Manufacturer, LLC | 08/04/1995SE |
| K920152 | Bubble TocoHFM · Traditional | Utah Medical Products, Inc. | 05/26/1993SE |
| K910282 | Medi-Trace(R) Disposable TocotonometerHFM · Traditional | Graphic Controls Corp. | 03/29/1991SE |
| K904691 | Air-Shields Vickers Telescan Telecom Display SystHFM · Traditional | Air-Shields Vickers, Inc. | 02/19/1991SE |
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| K131781 | Clearview TotalLKF · Traditional | 05/28/2014SE |
| K110605 | Rom PlusNQM · Traditional | 11/23/2011SE |
| K061539 | Gomco Circumcision Clamp, Mogen Clamp, Plastibell Circumcision DeviceHFX · Traditional | 09/20/2007SE |
| K030691 | Fetal Spiral Electrode, Model FSE07000HGP · Traditional | 09/17/2003SE |
| K022023 | Compass Esophageal Pressure Catheter, Model GIE-8500, Compass Ano-Rectal Pressure…KLA · Traditional | 01/07/2003SE |
Questions and answers
When was Koala Toco cleared by the FDA?
Koala Toco (K140163) received a 510(k) decision of Substantially Equivalent on May 29, 2014, 127 days after the submission was received.
What is the product code of K140163?
The FDA product code is HFM – Monitor, Uterine Contraction, External (For Use In Clinic), a Class II (moderate risk) device regulated under 21 CFR 884.2720.