# K013281: Versalab Apm

- Pathway: 510(k) (Abbreviated)
- Applicant: Nicolet Biomedical
- Decided: Apr 18, 2002 after 198 days
- Product code: HGM (System, Monitoring, Perinatal)
- Device class: 2
- Regulation: 21 CFR 884.2740
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The VersaLab APM, antepartum monitor is a Perinatal Monitoring system for non-invasively measuring and graphically showing both maternal abdominal contractions and the fetal heart rate by means of display on a non-permanent graphical display as well as a permanent record on a thermal strip chart printer. This data is intended to aid in assessing the well being of the fetus during the final trimester of pregnancy [Non-Stress Test]. This device is for use by trained medical personnel located in hospitals, clinics and doctor’s offices. The device is for non-invasive use only. The device is not to be used on or near non-intact skin. The device is not to be used on or near the eyes. The device is to be used by or on order of a physician.

Source page: https://510kreport.com/device/K013281
Methodology: https://510kreport.com/methodology