510(k) · Cleared
ClearedSeries 50XM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hewlett-Packard GmbH · HGM System, Monitoring, Perinatal
Cleared on Mar 8, 1996 as substantially equivalent to K900480 (Hewlett-Packard Co., 1990) after a 172-day review. Its family tree reaches back 1 generation to 1990. 98 later devices descend from it.
- Decided
- Mar 8, 1996
- Review
- 172 days
- Class
- Class II
- Product code
- HGM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K900480 (1990). 98 later devices descend from it, 6 citing it directly.
- Root · 1 generation backK900480 M1350A Fetal Monitor (Intrapartum)Hewlett-Packard Co. · 1990
- This deviceK954351 Series 50XMHewlett-Packard GmbH · 1996
- Descendant · cites it directly · 76 of its ownK023931 Philips Avalon CTS Cordless Fetal Transducer System, Models M2720A…Philips Medical Systems, Inc. · 2003
- Descendant · 2 generations on · 64 of its ownK100598 Penrith Elettra Ultrasound SystemPenrith Corporation · 2010
- Descendant · 3 generations on · 33 of its ownK151339 SONON Ultrasound Imaging System (Model: SONON 300C)Healcerion Co., Ltd. · 2015
- Descendant · 3 generations on · 29 of its ownK162417 Acuson Freestyle Ultrasound SystemSiemens Medi Cal Solutions, Inc. · 2016
- Descendant · 4 generations on · 28 of its ownK163138 Clarius Ultrasound SystemClarius Mobile Health Corp. · 2016
Showing 5 of 98 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 98 · See all- K023931Philips Avalon CTS Cordless Fetal Transducer System, Models M2720A, M2725A, M2726A, M2727APhilips Medical Systems, Inc. · 2003 · cites it directly76descendants
- K100598Penrith Elettra Ultrasound SystemPenrith Corporation · 2010 · 2 generations on64descendants
- K151339SONON Ultrasound Imaging System (Model: SONON 300C)Healcerion Co., Ltd. · 2015 · 3 generations on33descendants
- K162417Acuson Freestyle Ultrasound SystemSiemens Medi Cal Solutions, Inc. · 2016 · 3 generations on29descendants
- K163138Clarius Ultrasound SystemClarius Mobile Health Corp. · 2016 · 4 generations on28descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K900480 | M1350A Fetal Monitor (Intrapartum) | Hewlett-Packard Co. | 1990 | — |
| 0 (this device) | K954351 | Series 50XM | Hewlett-Packard GmbH | 1996 | — |
| +1 | K023931 | Philips Avalon CTS Cordless Fetal Transducer System, Models M2720A, M2725A… | Philips Medical Systems, Inc. | 2003 | — |
| +2 | K100598 | Penrith Elettra Ultrasound System | Penrith Corporation | 2010 | — |
| +3 | K151339 | SONON Ultrasound Imaging System (Model: SONON 300C) | Healcerion Co., Ltd. | 2015 | — |
| +3 | K162417 | Acuson Freestyle Ultrasound System | Siemens Medi Cal Solutions, Inc. | 2016 | — |
| +4 | K163138 | Clarius Ultrasound System | Clarius Mobile Health Corp. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 4 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 4 | 0 |
| 2015 | 5 | 0 |
| 2016 | 2 | 0 |
| 2017 | 6 | 0 |
| 2018 | 5 | 0 |
| 2019 | 2 | 0 |
| 2020 | 6 | 0 |
| 2021 | 6 | 0 |
| 2022 | 13 | 0 |
| 2023 | 8 | 0 |
| 2024 | 9 | 0 |
| 2025 | 9 | 0 |
| 2026 | 8 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HGM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HGM device
- #1 K241882 Fetal & Maternal Monitor (F15A, F15A Air)score 19.5 · 33 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K900480 | M1350A Fetal Monitor (Intrapartum)Summary page 1…ers and the recorder. The Series 50XM (M1350B) slightly modifies existing software modules of the Series 501X (M1350A) Fetal Monitor (which was originally cleared under K900480) and adds a new Software Modules for the maternal parameters, which were original transported from the predicate devices of HP.… | 1990 |
| * | — | Corometrics Model 118 Named without a submission number | |
| * | — | HP 78352C Named without a submission number | |
| * | — | M1020A Named without a submission number | |
| * | — | M1008B Named without a submission number |
What descends from it? (98)
See all 986 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K023931 | Philips Avalon CTS Cordless Fetal Transducer System, Models M2720A, M2725A, M2726A, M2727A | 2003 | 76 |
| K051366 | Piconibp Oem Module | 2005 | 10 |
| K052795 | Philips Avalon Fetal Monitor, Models FM20 and FM30 | 2005 | 9 |
| K112390 | Monica AN24 | 2012 | 8 |
| K101801 | Monica AN24 | 2011 | 8 |
| K132918 | Sense-4BABY System | 2013 | 1 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All HGM devicesHGM System, Monitoring, Perinatal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HGM
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HGM
269in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HGM
5in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HGM
99in 2025
MAUDE reports naming product code HGM, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 56 | 0 | 35 |
| 2008 | 4 | 75 | 4 | 17 |
| 2009 | 4 | 66 | 6 | 42 |
| 2010 | 4 | 193 | 0 | 64 |
| 2011 | 13 | 141 | 0 | 83 |
| 2012 | 4 | 107 | 0 | 44 |
| 2013 | 2 | — | 1 | 16 |
| 2014 | 4 | 231 | 1 | 30 |
| 2015 | 5 | 169 | 0 | 44 |
| 2016 | 1 | — | 0 | 17 |
| 2017 | 3 | 138 | 0 | 27 |
| 2018 | 3 | 258 | 0 | 30 |
| 2019 | 0 | — | 5 | 41 |
| 2020 | 1 | — | 0 | 19 |
| 2021 | 0 | — | 0 | 71 |
| 2022 | 1 | — | 0 | 87 |
| 2023 | 2 | — | 0 | 69 |
| 2024 | 1 | — | 0 | 174 |
| 2025 | 4 | 269 | 0 | 99 |
| 2026 | 2 | — | 2 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K954351 · printed Nov 6, 2026
Cite this page
510(k) Report. “K954351: Series 50XM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K954351
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026