# K954351: Series 50XM

- Pathway: 510(k) (Traditional)
- Applicant: Hewlett-Packard GmbH
- Decided: Mar 8, 1996 after 172 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 K900480 (1990). 1 ancestor in all.
98 later devices descend from it; 6 cite it directly.
0 of 100 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 1.
- (no number) Corometrics Model 118: named in the summary without a submission number
- (no number) HP 78352C: named in the summary without a submission number
- (no number) M1020A: named in the summary without a submission number
- (no number) M1008B: named in the summary without a submission number

## Most influential descendants
- K023931: Philips Avalon CTS Cordless Fetal Transducer System, Models M2720A, M2725A, M2726A, M2727A (2003), 76 descendants of its own
- K100598: Penrith Elettra Ultrasound System (2010), 64 descendants of its own
- K151339: SONON Ultrasound Imaging System (Model: SONON 300C) (2015), 33 descendants of its own
- K162417: Acuson Freestyle Ultrasound System (2016), 29 descendants of its own
- K163138: Clarius Ultrasound System (2016), 28 descendants of its own

## Indications for use
It allows non- invasive or invasive monitoring of an ambulant patient during both antepartum testing and labor and delivery in that the monitoring of the FHR via ultrasound or direct ECG, and uterine activity via an external Toco transducer or an internal IUP transducer is possible, additionally it allow maternal heart rate recording via the MECG transducer. It allows the non-invasive measurement of the Noninvasive Bloodpressure ans the Oxygen Saturation ,generate alarms, and generate recording on maternal patients.

Source page: https://510kreport.com/device/K954351
Methodology: https://510kreport.com/methodology