Cleared Traditional

K140163 - KOALA TOCO

K140163 is an FDA 510(k) clearance for KOALA TOCO, manufactured by Clinical Innovations, LLC. The device is a Class 2 Obstetrics & Gynecology device with product code HFM cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K140163 · Clinical Innovations, LLC · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2014
Decision
127d
Days
Class 2
Risk

K140163 is an FDA 510(k) clearance for the KOALA TOCO. Classified as Monitor, Uterine Contraction, External (for Use In Clinic) (product code HFM), Class II - Special Controls.

Submitted by Clinical Innovations, LLC (Marlborough, US). The FDA issued a Cleared decision on May 29, 2014 after a review of 127 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.2720 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Clinical Innovations, LLC devices

FDA 510(k) Submission Details - K140163

510(k) Number K140163 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 2014
Decision Date May 29, 2014
Days to Decision 127 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 161d · This submission: 127d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HFM Device Classification - Class 2, Special Controls

Product Code HFM Monitor, Uterine Contraction, External (for Use In Clinic)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.2720
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HFM Monitor, Uterine Contraction, External (for Use In Clinic)

All 11
Devices cleared under the same product code (HFM) and FDA review panel - the closest regulatory comparables to K140163.
FEATHERLITE AQUA TOCODYNAMOMETER
K061044 · Ventrex, Inc. · Jul 2006
TOCO LITE, MODEL TD-01
K013477 · Ventrex, Inc. · Jan 2002
SECURELINE DISPOSABLE FETAL MONITORING STRAPS #3860 AND #3565
K994353 · Precision Dynamics Corp. · Mar 2000
TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING
K992811 · Epic Medical Equipment Services, Inc. · Jan 2000
DISCO UTERINE CONTRACTION TRANSDUCER & ACCESSORIES
K954847 · Ocg Systems, Inc. · May 1996
BUBBLE TOCO
K920152 · Utah Medical Products, Inc. · May 1993