# K153262: PUREtrace™

- Pathway: 510(k) (Traditional)
- Applicant: Nemo Healthcare BV
- Decided: Feb 7, 2017 after 455 days
- Product code: OSP (Uterine Electromyographic Monitor)
- 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: 3 generations back to K900480 (1990). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112390: Monica AN24, Monica Healthcare, Ltd. (2012) Summary page 4.

## Indications for use
PUREtrace™ is an electromyography (EMG) device that non-invasively measures intrapartum uterine activity. PUREtrace™ is indicated for use on women who are at term (≥37 completed weeks), in labor, with singleton pregnancies. The signal is acquired from surface electrodes that are placed on the maternal abdomen. PUREtrace™ is intended for use by healthcare professionals in a clinical setting.

Source page: https://510kreport.com/device/K153262
Methodology: https://510kreport.com/methodology