# K061044: Featherlite Aqua Tocodynamometer

- Pathway: 510(k) (Traditional)
- Applicant: Ventrex, Inc.
- Decided: Jul 12, 2006 after 89 days
- Product code: HFM (Monitor, Uterine Contraction, External (For Use In Clinic))
- Device class: 2
- Regulation: 21 CFR 884.2720
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K891595 (1989). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013477: Toco Lite, Model TD-01, Ventrex, Inc. (2002) Summary page 1.
- K982651: Corometrics Model 5700 and 2264 Watertight Transducer, Corometrics Medical Systems, Inc. (1998) Summary page 1.

## Indications for use
The FeatherLite AquaTMToco dynamometer is intended for use in conjunction with telemetry systems for standard fetal monitors for the evaluation of external uterine activity during antepartum and intrapartum periods. Is should only be used in a clinical setting. It may be fully submerged in water for water birthing or monitoring in a whirlpool. Caution: FeatherLite AquaTMToco is not intended for home monitoring of pre-term labor. Placement over the fundal area of the uterus to the left or right of the midline is suitable for most patients, It is held on the surface of the abdomen using a standard button hole or VelcroTM type belt. The product is supplied non-sterile and is intended for single use only.

Source page: https://510kreport.com/device/K061044
Methodology: https://510kreport.com/methodology