510(k) · Cleared
ClearedSonicaid Team3 Antepartum, Sonicaid Team3 Intrapartum
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Huntleigh Healthcare Limited · HGM System, Monitoring, Perinatal
Cleared on Jun 24, 2020 as substantially equivalent to K090285 (Huntleigh Healthcare, Ltd., 2009) after a 72-day review. Its family tree reaches back 6 generations to 1987. 3 later devices descend from it.
- Decided
- Jun 24, 2020
- Review
- 72 days
- Class
- Class II
- Product code
- HGM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K864318 (1987). 15 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 5 generations backK952979 Hanc NetworkHealthtech Services Corp. · 1996
- 4 generations backK964408 Poseidon Cardiac Monitoring System (PCMS)Instromedix, Inc. · 1997
- 3 generations backK033410 Tempus 2000 Patient Monitor, Model 00-0002Remote Diagnostic Technologies, Ltd. · 2004
- 2 generations backK082718 Tempusic Patient MonitorRemote Diagnostic Technologies, Ltd. · 2008
- 1 generation backK090285 Sonicaid FM820 and FM830 EncoreHuntleigh Healthcare, Ltd. · 2009
- This deviceK200975 Sonicaid Team3 Antepartum, Sonicaid Team3 IntrapartumHuntleigh Healthcare Limited · 2020
- Descendant · cites it directly · 2 of its ownK241368 Sonicaid Team3Huntleigh Healthcare, Ltd. · 2025
- Descendant · 2 generations on · 1 of its ownK250777 Sonicaid Team3Huntleigh Healthcare, Ltd. · 2025
- Descendant · 3 generations on · 0 of its ownK253021 ANNE MaternalSibel Health, Inc. · 2026
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K864318 | The Buddy System/Health Information System | The Buddy Systems, Inc. | 1987 | — |
| −5 | K952979 | Hanc Network | Healthtech Services Corp. | 1996 | — |
| −4 | K964408 | Poseidon Cardiac Monitoring System (PCMS) | Instromedix, Inc. | 1997 | — |
| −3 | K033410 | Tempus 2000 Patient Monitor, Model 00-0002 | Remote Diagnostic Technologies, Ltd. | 2004 | — |
| −2 | K082718 | Tempusic Patient Monitor | Remote Diagnostic Technologies, Ltd. | 2008 | — |
| −1 | K090285 | Sonicaid FM820 and FM830 Encore | Huntleigh Healthcare, Ltd. | 2009 | — |
| 0 (this device) | K200975 | Sonicaid Team3 Antepartum, Sonicaid Team3 Intrapartum | Huntleigh Healthcare Limited | 2020 | — |
| +1 | K241368 | Sonicaid Team3 | Huntleigh Healthcare, Ltd. | 2025 | — |
| +2 | K250777 | Sonicaid Team3 | Huntleigh Healthcare, Ltd. | 2025 | — |
| +3 | K253021 | ANNE Maternal | Sibel Health, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 2 | 0 |
| 2026 | 1 | 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? (1)
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 |
|---|---|---|---|
| * | K090285 | Sonicaid FM820 and FM830 EncoreSummary page 4…non-invasive Regulatory Class: II Review Panel: Obstetrics/Gynecology 5.2 Predicate Device Information Predicate Device: Sonicaid FM820E and FM830E (K090285) manufactured by Huntleigh Healthcare Ltd., Diagnostic Products Division. The predic… | 2009 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K241368 | Sonicaid Team3 | 2025 | 2 |
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?
- The line of descent spans 33 years and passes through 6 companies; a new generation was cleared every 6.6 years on median.
- None of the 15 ancestors has a recall.
- Of its descendants, K241368 (Huntleigh Healthcare, Ltd., 2025) has gone furthest, with 2 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. 2020, this device’s year, is highlighted.
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?
The Sonicaid Team3 Antepartum and Sonicaid Team3 Intrapartum fetal monitors (Team3 fetal monitors) are indicated for use by trained healthcare professionals in non-invasive and invasive monitoring of physiological parameters in pregnant women and fetuses, during the antepartum and intrapartum periods of pregnancy. The Team3 fetal monitors are intended for pregnant women from the 28th week of gestation, through to term and delivery. The devices are…
Read the full statement (204 words)
The Sonicaid Team3 Antepartum and Sonicaid Team3 Intrapartum fetal monitors (Team3 fetal monitors) are indicated for use by trained healthcare professionals in non-invasive and invasive monitoring of physiological parameters in pregnant women and fetuses, during the antepartum and intrapartum periods of pregnancy. The Team3 fetal monitors are intended for pregnant women from the 28th week of gestation, through to term and delivery. The devices are intended for use in clinical and hospital-type facilities.
Sonicaid Team3 Antepartum is suitable for use when there is a need to monitor the following physiological applications:
1) Single or twin fetal heart rates by means of ultrasound
2) Uterine activity - externally sensed
3) Fetal movement - maternally sensed and externally via ultrasound
4) Maternal heart rate and oxygen saturation via pulse oximetry
5) Maternal non-invasive blood pressure
Sonicaid Team3 Intrapartum is suitable for use when there is a need to monitor the following physiological applications:
1) Single or twin fetal heart rates by means of ultrasound and/or FECG
2) Maternal heart rate via ECG electrodes
3) Uterine activity - externally or internally sensed
4) Fetal movement - maternally sensed and externally via ultrasound
5) Maternal heart rate and oxygen saturation via pulse oximetry
6) Maternal non-invasive blood pressure
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200975 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200975: Sonicaid Team3 Antepartum, Sonicaid Team3 Intrapartum.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200975
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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