# K051903: Fetalgard Lite-Nibp, Model FGL-Nibp

- Pathway: 510(k) (Traditional)
- Applicant: Analogic Corporation
- Decided: Dec 27, 2005 after 167 days
- Product code: DXN (System, Measurement, Blood-Pressure, Non-Invasive)
- Device class: 2
- Regulation: 21 CFR 870.1130
- 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 K962424 (1996). 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)
- K002503: Fetalgard Lite, Analogic Corp. (2000) Summary page 2.
- K030931: C3 Patient Monitor, Analogic Corp. (2003) Summary page 2.

## Indications for use
The FETALGARD Lite-NIBP is a Perinatal Monitoring System for non-invasively measuring and showing graphically abdominal contractions, fetal heart rate, maternal non-invasive blood pressure, and maternal heart rate by means of display on a non-permanent graphical display and optionally on a printer. This data is to aid in assessing the well-being of the fetus and mother during the final trimester of pregnancy (non-stress test). This device is for use only by trained medical personnel located in hospitals, clinics, doctors' offices, and patient's home.

Source page: https://510kreport.com/device/K051903
Methodology: https://510kreport.com/methodology