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Koala TOCO

FDA 510(k)

Class II (US FDA 510(k))

510(k) K140163

by Clinical Innovations, LLC

Identifiers

510(k) Number
K140163 FDA 510(k)
FDA Product Code
HFM FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 884.2720 FDA 510(k)
Regulation Number
884.2720 FDA 510(k)
Advisory Committee
Obstetrics/Gynecology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Koala TOCO is a Monitor, Uterine Contraction, External (For Use In Clinic) designed to measure and display relative external uterine activity. It functions as a pneumatic tocodynamometer, utilizing a guard-ring with a thin elastic membrane to detect contraction frequency and duration during antepartum and intrapartum periods.

This device is supplied as a single-use, non-sterile disposable unit, intended for use in clinical settings alongside standard fetal monitors. It adheres to FDA 510(k) clearance (K140163) under regulatory classification Class II (HFM) and is approved for obstetrics/gynecology applications. Storage and handling follow standard medical device protocols, with no MRI compatibility specified.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PDF K140163 - Food and Drug Administration, KOALA TOCO (K140163) — FDA 510 (k) | Innolitics, Koala Toco 510 (k) FDA Premarket Notification K140163 CLINICAL ..., Koala Toco® - BEUDAMED

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Clinical Innovations, LLC

Sources (1)

  • FDA 510(k) K140163 24 fields · synced Sep 18, 2026