# K991905: Corometrics Model 171 and 172 Fetal Monitor

- Pathway: 510(k) (Traditional)
- Applicant: General Electric Medical Systems Information Techn
- Decided: Sep 1, 1999 after 89 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
Longest line of descent: 1 generation back to K852608 (1985). 2 ancestors in all.
16 later devices descend from it; 3 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K920376: Corometrics Model 150 Fetal Monitor, Ge Medical Systems Information Technologies (1992) Summary page 1.
- K852608: Spectra 400 Extended Surveillance & Alert System, Ge Medical Systems Information Technologies (1985) Summary page 1.

## Most influential descendants
- K040903: Cadence, Models 2001 and 2002 (2004), 12 descendants of its own
- K073221: Cadence II (2007), 11 descendants of its own
- K082602: Fetal & Maternal Monitor, Model F6, F9 (2008), 6 descendants of its own
- K100797: Fetal Maternal Monitor Model F9 Express and Express (2010), 5 descendants of its own
- K082369: Cadence, Cadence Dual, Cadence II Fetal Monitor (2008), 4 descendants of its own

## Indications for use
I. Fetal Surveillance The Corometrics® Model 171/172 Series Monitors are used for monitoring of the fetus during the antepartum period as well as throughout labor and delivery (i.c. fetal heart rate and uterine activity monitoring). The device also has an optional monitoring mode to detect fetal body movements. II. Maternal NBP Recording Blood Pressure. The monitor has an interface to select external NBP monitors. The Monitor does not process any NBP data but only prints the NBP data, from the external monitor, to its chart recorder.

Source page: https://510kreport.com/device/K991905
Methodology: https://510kreport.com/methodology