510(k) · Cleared
ClearedSonicaid FM820 and FM830 Encore
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 Jul 15, 2009 as substantially equivalent to K002150 (Oxford Instruments, 2001) and 1 other predicate after a 160-day review. Its family tree reaches back 5 generations to 1987. 4 later devices descend from it.
- Decided
- Jul 15, 2009
- Review
- 160 days
- Class
- Class II
- Product code
- HGM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K864318 (1987). 14 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 4 generations backK952979 Hanc NetworkHealthtech Services Corp. · 1996
- 3 generations backK964408 Poseidon Cardiac Monitoring System (PCMS)Instromedix, Inc. · 1997
- 2 generations backK033410 Tempus 2000 Patient Monitor, Model 00-0002Remote Diagnostic Technologies, Ltd. · 2004
- 1 generation backK082718 Tempusic Patient MonitorRemote Diagnostic Technologies, Ltd. · 2008
- This deviceK090285 Sonicaid FM820 and FM830 EncoreHuntleigh Healthcare, Ltd. · 2009
- Descendant · cites it directly · 3 of its ownK200975 Sonicaid Team3 Antepartum, Sonicaid Team3 IntrapartumHuntleigh Healthcare Limited · 2020
- Descendant · 2 generations on · 2 of its ownK241368 Sonicaid Team3Huntleigh Healthcare, Ltd. · 2025
- Descendant · 3 generations on · 1 of its ownK250777 Sonicaid Team3Huntleigh Healthcare, Ltd. · 2025
- Descendant · 4 generations on · 0 of its ownK253021 ANNE MaternalSibel Health, Inc. · 2026
Most influential descendants
Showing 4 of 4 · See all- K200975Sonicaid Team3 Antepartum, Sonicaid Team3 IntrapartumHuntleigh Healthcare Limited · 2020 · cites it directly3descendants
- K241368Sonicaid Team3Huntleigh Healthcare, Ltd. · 2025 · 2 generations on2descendants
- K250777Sonicaid Team3Huntleigh Healthcare, Ltd. · 2025 · 3 generations on1descendant
- K253021ANNE MaternalSibel Health, Inc. · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K864318 | The Buddy System/Health Information System | The Buddy Systems, Inc. | 1987 | — |
| −4 | K952979 | Hanc Network | Healthtech Services Corp. | 1996 | — |
| −3 | K964408 | Poseidon Cardiac Monitoring System (PCMS) | Instromedix, Inc. | 1997 | — |
| −2 | K033410 | Tempus 2000 Patient Monitor, Model 00-0002 | Remote Diagnostic Technologies, Ltd. | 2004 | — |
| −1 | K082718 | Tempusic Patient Monitor | Remote Diagnostic Technologies, Ltd. | 2008 | — |
| 0 (this device) | K090285 | Sonicaid FM820 and FM830 Encore | Huntleigh Healthcare, Ltd. | 2009 | — |
| +1 | K200975 | Sonicaid Team3 Antepartum, Sonicaid Team3 Intrapartum | Huntleigh Healthcare Limited | 2020 | — |
| +2 | K241368 | Sonicaid Team3 | Huntleigh Healthcare, Ltd. | 2025 | — |
| +3 | K250777 | Sonicaid Team3 | Huntleigh Healthcare, Ltd. | 2025 | — |
| +4 | 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 |
|---|---|---|
| 2020 | 1 | 0 |
| 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? (2)
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 |
|---|---|---|---|
| * | K002150 | Sonicaid FM820, Sonicaid FM830Summary page 2…evice &Accessories 5.3 IDENTIFICATION OF LEGALLY MARKETED DEVICES TO WHICH EQUIVALENCE IS CLAIMED Predicate Device 1: Sonicaid FM830 (k002150) Predicate Device 2: RDT Limited Tempus ICTM Patient Monitor (k082718) 5.4 NEW DEVICE DESCRIPTIO… | 2001 |
| * | K082718 | Tempusic Patient MonitorSummary page 2…ED Predicate Device 1: Sonicaid FM830 (k002150) Predicate Device 2: RDT Limited Tempus ICTM Patient Monitor (k082718) 5.4 NEW DEVICE DESCRIPTION 5.4.1 Outline The FM820E and FM830E are fetal/maternal monitors designed for use in clinical and ho… | 2008 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200975 | Sonicaid Team3 Antepartum, Sonicaid Team3 Intrapartum | 2020 | 3 |
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 22 years and passes through 5 companies; a new generation was cleared every 4.6 years on median.
- None of the 14 ancestors has a recall.
- Of its descendants, K200975 (Huntleigh Healthcare Limited, 2020) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K002150.
How does its category compare?
All HGM devicesHGM System, Monitoring, Perinatal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 Huntleigh Healthcare Ltd Sonicaid FM820 and FM830 Encore fetal monitors are indicated for use by trained healthcare professionals in non-invasive and invasive monitoring of physiological parameters in pregnant adult human females, and fetuses, during the intrapartum and antepartum periods of pregnancy. The devices are intended for use in clinical and hospital-type facilities. They are not intended for use in intensive care units, operating rooms or…
Read the full statement (181 words)
The Huntleigh Healthcare Ltd Sonicaid FM820 and FM830 Encore fetal monitors are indicated for use by trained healthcare professionals in non-invasive and invasive monitoring of physiological parameters in pregnant adult human females, and fetuses, during the intrapartum and antepartum periods of pregnancy. The devices are intended for use in clinical and hospital-type facilities. They are not intended for use in intensive care units, operating rooms or in transport monitoring applications.
Sonicaid FM820E is suitable for use when there is a need to monitor the following physiological parameters:
* Single or twin fetal heart rates by means of ultrasound
* Fetal or maternal heart rate via ECG
Uterine activity - externally or internally sensed
* Fetal movement - maternally sensed.
Sonicaid FM830E is suitable for use when there is a need to monitor the following physiological parameters:
* Single or twin fetal heart rates by means of ultrasound
Fetal or maternal heart rate via ECG
Uterine activity - externally or internally sensed
* Fetal movement - maternally 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/K090285 · printed Nov 3, 2026
Cite this page
510(k) Report. “K090285: Sonicaid FM820 and FM830 Encore.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K090285
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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