Cleared Traditional

K061044 - FEATHERLITE AQUA TOCODYNAMOMETER

K061044 is an FDA 510(k) clearance for FEATHERLITE AQUA TOCODYNAMOMETER, manufactured by Ventrex, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HFM cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K061044 · Ventrex, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2006
Decision
89d
Days
Class 2
Risk

K061044 is an FDA 510(k) clearance for the FEATHERLITE AQUA TOCODYNAMOMETER. Classified as Monitor, Uterine Contraction, External (for Use In Clinic) (product code HFM), Class II - Special Controls.

Submitted by Ventrex, Inc. (Ventura, US). The FDA issued a Cleared decision on July 12, 2006 after a review of 89 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ventrex, Inc. devices

FDA 510(k) Submission Details - K061044

510(k) Number K061044 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 2006
Decision Date July 12, 2006
Days to Decision 89 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 160d · This submission: 89d
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 7
Devices cleared under the same product code (HFM) and FDA review panel - the closest regulatory comparables to K061044.
SECURELINE DISPOSABLE FETAL MONITORING STRAPS #3860 AND #3565
K994353 · Precision Dynamics Corp. · Mar 2000
BUBBLE TOCO
K920152 · Utah Medical Products, Inc. · May 1993
MEDI-TRACE(R) DISPOSABLE TOCOTONOMETER
K910282 · Graphic Controls Corp. · Mar 1991
MODEL 37 UTERINE CONTRACTION ACTIVITY MONITOR
K894030 · Healthdyne, Inc. · Jan 1990
MODEL NUMBER (TBD) TOCO DATA TELEPHONE TRANS. SYS.
K882080 · Aequitron Medical, Inc. · Mar 1989
EXTERNAL UTERINE CONTRACTION MONITOR-TOKODYNAMOMET
K853856 · Aequitron Medical, Inc. · Mar 1986