510(k) · Cleared
ClearedModel M1310A, Series 50T Fetal Telemetry System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hewlett-Packard Co. · HGM System, Monitoring, Perinatal
Cleared on Aug 15, 1994 after a 56-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 81 later devices descend from it.
- Decided
- Aug 15, 1994
- Review
- 56 days
- Class
- Class II
- Product code
- HGM
- Recalls
- None
- Predicates
- 0
81 later devices descend from it, 2 citing it directly.
- This deviceK942887 Model M1310A, Series 50T Fetal Telemetry SystemHewlett-Packard Co. · 1994
- 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 81 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 81 · 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 |
|---|---|---|---|---|---|
| 0 (this device) | K942887 | Model M1310A, Series 50T Fetal Telemetry System | Hewlett-Packard Co. | 1994 | — |
| +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 |
|---|---|---|
| 1998 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 5 | 0 |
| 2018 | 4 | 0 |
| 2019 | 2 | 0 |
| 2020 | 5 | 0 |
| 2021 | 6 | 0 |
| 2022 | 12 | 0 |
| 2023 | 7 | 0 |
| 2024 | 9 | 0 |
| 2025 | 9 | 0 |
| 2026 | 8 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (81)
See all 812 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K023931 (Philips Medical Systems, Inc., 2003) has gone furthest, with 76 descendants of its own.
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 | — |
https://510kreport.com/device/K942887 · printed Nov 4, 2026
Cite this page
510(k) Report. “K942887: Model M1310A, Series 50T Fetal Telemetry System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K942887
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026