Koala Toco®
Koala Toco is a disposable external contraction sensor used with standard fetal monitors in a clinical setting. It detects changes in the mother's abdomen as the uterus contracts, allowing…
Koala Toco is a disposable external contraction sensor used with standard fetal monitors in a clinical setting. It detects changes in the mother’s abdomen as the uterus contracts, allowing evaluation of contraction frequency and duration during the antepartum and intrapartum periods.
A thin elastic membrane spans a shallow depression in a guard ring and traps a small volume of air. An air channel connects this space to a pressure transducer in the Koala IUP/TOCO reusable cable. Abdominal pressure changes are transmitted pneumatically to the transducer.
Listed Item
Koala Toco® Single-Use Tocodyamometer
Cable and Use Setting
The sensor and reusable cable are compatible with Philips and Corometrics monitors. The cable can separately connect to a Koala intrauterine pressure catheter for intrapartum internal pressure monitoring. Koala Toco itself is supplied nonsterile for single use and is not intended for home monitoring of preterm labor.
Who Else Makes It
All of them in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Orantech Inc. | Shenzhen | Guangdong | Contract manufacturer | 40 |
Record
| Listed by | Clinical Innovations, LLC, United States |
|---|---|
| FDA product code | HFM |
| Device type | Monitor, Uterine Contraction, External (For Use In Clinic) |
| Device class | Class 2 |
| Regulation | 21 CFR 884.2720 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K140163 |
| Record published | 2016-09-01 |
| Record revised | 2022-11-28 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Pack of 4, pack of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| KDT-1000 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Featherlite Toco | Parker Hannifin Corp. | 8 |
| Featherlite Toco Plus | Parker Hannifin Corp. | 4 |
| AIV | American IV Products, Inc. | 3 |
| Featherlite Aqua | Parker Hannifin Corp. | 2 |
| Avalon Toco MP Transducer | Philips Medizin Systeme Böblingen GmbH | 2 |
| Monitor, Uterine Contraction, External (For Use In Clinic) | Wipro GE Healthcare Private Ltd. | 2 |
| Toco Transducer | Wipro GE Healthcare Private Ltd. | 1 |
| Avalon CL Toco+ MP Transducer | Philips Medizin Systeme Böblingen GmbH | 1 |
| Avalon Toco+ Transducer | Philips Medizin Systeme Böblingen GmbH | 1 |
| Avalon Fetal & Maternal Patch | Philips Medical Systems Hsg | 1 |
| Avalon CL Fetal & Maternal Pod | Philips Medizin Systeme Böblingen GmbH | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K140163 | 2014-05-29 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P890063 | 1990-09-12 | GENESIS(R) HOME UTERINE ACTIVITY MONITORING SYSTEM | Matria Healthcare, Inc. |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.