510(k) · Cleared
ClearedSonicaid Team3
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Huntleigh Healthcare, Ltd. · HGM System, Monitoring, Perinatal
Cleared on Sep 19, 2025 as substantially equivalent to K241368 (Huntleigh Healthcare, Ltd., 2025) after a 189-day review. Its family tree reaches back 8 generations to 1987. 1 later device descends from it.
- Decided
- Sep 19, 2025
- Review
- 189 days
- Class
- Class II
- Product code
- HGM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K864318 (1987). 17 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 7 generations backK952979 Hanc NetworkHealthtech Services Corp. · 1996
- 6 generations backK964408 Poseidon Cardiac Monitoring System (PCMS)Instromedix, Inc. · 1997
- 5 generations backK033410 Tempus 2000 Patient Monitor, Model 00-0002Remote Diagnostic Technologies, Ltd. · 2004
- 4 generations backK082718 Tempusic Patient MonitorRemote Diagnostic Technologies, Ltd. · 2008
- 3 generations backK090285 Sonicaid FM820 and FM830 EncoreHuntleigh Healthcare, Ltd. · 2009
- 2 generations backK200975 Sonicaid Team3 Antepartum, Sonicaid Team3 IntrapartumHuntleigh Healthcare Limited · 2020
- 1 generation backK241368 Sonicaid Team3Huntleigh Healthcare, Ltd. · 2025
- This deviceK250777 Sonicaid Team3Huntleigh Healthcare, Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK253021 ANNE MaternalSibel Health, Inc. · 2026
Most influential descendants
Showing 1 of 1 · See all- K253021ANNE MaternalSibel Health, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K864318 | The Buddy System/Health Information System | The Buddy Systems, Inc. | 1987 | — |
| −7 | K952979 | Hanc Network | Healthtech Services Corp. | 1996 | — |
| −6 | K964408 | Poseidon Cardiac Monitoring System (PCMS) | Instromedix, Inc. | 1997 | — |
| −5 | K033410 | Tempus 2000 Patient Monitor, Model 00-0002 | Remote Diagnostic Technologies, Ltd. | 2004 | — |
| −4 | K082718 | Tempusic Patient Monitor | Remote Diagnostic Technologies, Ltd. | 2008 | — |
| −3 | K090285 | Sonicaid FM820 and FM830 Encore | Huntleigh Healthcare, Ltd. | 2009 | — |
| −2 | K200975 | Sonicaid Team3 Antepartum, Sonicaid Team3 Intrapartum | Huntleigh Healthcare Limited | 2020 | — |
| −1 | K241368 | Sonicaid Team3 | Huntleigh Healthcare, Ltd. | 2025 | — |
| 0 (this device) | K250777 | Sonicaid Team3 | Huntleigh Healthcare, Ltd. | 2025 | — |
| +1 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K241368 | Sonicaid Team3Summary page 5…2. Predicate Device Predicate Device: Sonicaid Team3 Fetal Monitor, manufactured by Huntleigh Healthcare Ltd., cleared under K241368 The predicate device has not been subject to a design related recall. Huntleigh Healthcare Ltd. Page 5.3… | 2025 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K253021 | ANNE Maternal | 2026 | 0 |
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 38 years and passes through 6 companies; a new generation was cleared every 4.6 years on median.
- None of the 17 ancestors has a recall.
- Of its descendants, K253021 (Sibel Health, Inc., 2026) has gone furthest, with 0 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. 2025, 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 Team3 fetal monitors are indicated for use by trained healthcare professionals in noninvasive 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 with singleton or twin pregnancies from the 28th week of gestation, through to term and delivery. In cases of triplet, the Team3 fetal monitors are intended for…
Read the full statement (290 words)
The Team3 fetal monitors are indicated for use by trained healthcare professionals in noninvasive 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 with singleton or twin pregnancies from the 28th week of gestation, through to term and delivery.
In cases of triplet, the Team3 fetal monitors are intended for use from 30th week of gestation through 35 weeks gestation. 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:
• Single, twin or triplet fetal heart rates by means of ultrasound
• Uterine activity - externally sensed
• Manual fetal movement detection - maternally identified using the event marker
• Automatic fetal movement detection (defaults to OFF / Not for use in twin or triplet pregnancies)
• Maternal heart rate and oxygen saturation via pulse oximetry
• Maternal non-invasive blood pressure
• The DAWES REDMAN Cardiotocography (CTC) analysis output - advises whether a number of defined criteria indicative of a normal cardiotocograph record has been met for singleton pregnancies but not for triplet pregnancies. It provides nonspecific analysis in twin pregnancies due to nonspecific fetal movement input
Sonicaid Team3 Intrapartum is suitable for use when there is a need to monitor the following Physiological applications:
• Single, twin or triplet fetal heart rates by means of ultrasound and/or FECG
• Manual fetal movement detection - maternally identified using the event marker
• Maternal heart rate via ECG electrodes
• Uterine activity - externally or internally sensed
• Maternal heart rate and oxygen saturation via pulse oximetry
• Maternal non-invasive blood pressure
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250777 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250777: Sonicaid Team3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250777
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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