# K013477: Toco Lite, Model TD-01

- Pathway: 510(k) (Traditional)
- Applicant: Ventrex, Inc.
- Decided: Jan 17, 2002 after 90 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: 1 generation back to K843385 (1984). 2 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K900480: M1350A Fetal Monitor (Intrapartum), Hewlett-Packard Co. (1990) Summary page 2.
- K843385: Corometrics 115 Fetal Monitor, Ge Medical Systems Information Technologies (1984) Summary page 2.

## Most influential descendants
- K090145: Surecall Emg Labor Monitor (2011), 2 descendants of its own
- K140163: Koala Toco (2014), 0 descendants of its own
- K131889: Eum 100PRO (2014), 0 descendants of its own
- K130002: Surecall Labor Monitor (2013), 0 descendants of its own
- K061044: Featherlite Aqua Tocodynamometer (2006), 0 descendants of its own

## Indications for use
The FeatherLite Toco tocodynamometer is intended for use in conjunction with standard fetal monitors for the evaluation of external uterine activity during antepartum and intrapartum periods. It should only be used in a clinical setting. Caution: The FeatherLite Toco 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 in place on the surface of the abdomen using the attached elastic belt. The product is supplied non-sterile and is intended for single use or limited reuse following appropriate cleaning per hospital protocol.

Source page: https://510kreport.com/device/K013477
Methodology: https://510kreport.com/methodology