510(k) · Cleared
ClearedANNE Maternal
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sibel Health, Inc. · HGM System, Monitoring, Perinatal
Cleared on Feb 26, 2026 as substantially equivalent to K250777 (Huntleigh Healthcare, Ltd., 2025) after a 160-day review. Its family tree reaches back 9 generations to 1987.
- Decided
- Feb 26, 2026
- Review
- 160 days
- Class
- Class II
- Product code
- HGM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K864318 (1987). 18 ancestors in all. No later device cites it as a predicate yet.
- Root · 9 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 5 generations between
- 3 generations backK200975 Sonicaid Team3 Antepartum, Sonicaid Team3 IntrapartumHuntleigh Healthcare Limited · 2020
- 2 generations backK241368 Sonicaid Team3Huntleigh Healthcare, Ltd. · 2025
- 1 generation backK250777 Sonicaid Team3Huntleigh Healthcare, Ltd. · 2025
- This deviceK253021 ANNE MaternalSibel Health, Inc. · 2026
Show all 9 generations
- Root · 9 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 8 generations backK952979 Hanc NetworkHealthtech Services Corp. · 1996
- 7 generations backK964408 Poseidon Cardiac Monitoring System (PCMS)Instromedix, Inc. · 1997
- 6 generations backK033410 Tempus 2000 Patient Monitor, Model 00-0002Remote Diagnostic Technologies, Ltd. · 2004
- 5 generations backK082718 Tempusic Patient MonitorRemote Diagnostic Technologies, Ltd. · 2008
- 4 generations backK090285 Sonicaid FM820 and FM830 EncoreHuntleigh Healthcare, Ltd. · 2009
- 3 generations backK200975 Sonicaid Team3 Antepartum, Sonicaid Team3 IntrapartumHuntleigh Healthcare Limited · 2020
- 2 generations backK241368 Sonicaid Team3Huntleigh Healthcare, Ltd. · 2025
- 1 generation backK250777 Sonicaid Team3Huntleigh Healthcare, Ltd. · 2025
- This deviceK253021 ANNE MaternalSibel Health, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K864318 | The Buddy System/Health Information System | The Buddy Systems, Inc. | 1987 | — |
| −8 | K952979 | Hanc Network | Healthtech Services Corp. | 1996 | — |
| −7 | K964408 | Poseidon Cardiac Monitoring System (PCMS) | Instromedix, Inc. | 1997 | — |
| −6 | K033410 | Tempus 2000 Patient Monitor, Model 00-0002 | Remote Diagnostic Technologies, Ltd. | 2004 | — |
| −5 | K082718 | Tempusic Patient Monitor | Remote Diagnostic Technologies, Ltd. | 2008 | — |
| −4 | K090285 | Sonicaid FM820 and FM830 Encore | Huntleigh Healthcare, Ltd. | 2009 | — |
| −3 | K200975 | Sonicaid Team3 Antepartum, Sonicaid Team3 Intrapartum | Huntleigh Healthcare Limited | 2020 | — |
| −2 | K241368 | Sonicaid Team3 | Huntleigh Healthcare, Ltd. | 2025 | — |
| −1 | K250777 | Sonicaid Team3 | Huntleigh Healthcare, Ltd. | 2025 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K250777 | Sonicaid Team3Summary page 5…fication Codes: MSX, MWI, KMI, DRG Regulatory Class: Class II III. Predicate Device Trade Name: Sonicaid Team3 510(k) Number: K250777 Device Manufacturer: Huntleigh Healthcare Ltd The predicate device has not been subject to a desig… | 2025 |
What descends from it?
No later submission names this one as a predicate yet.
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 39 years and passes through 7 companies; a new generation was cleared every 4.6 years on median.
- None of the 18 ancestors has a recall.
How does its category compare?
All HGM devicesHGM System, Monitoring, Perinatal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 ANNE® Maternal system is a perinatal monitoring platform intended for the continuous collection, display, and storage of physiological data and vital signs from compatible medical devices in clinical settings. The system supports data acquisition from sensors, clinician inputted data, and compatible software for maternal and fetal monitoring in singleton pregnancies. Examples of parameters include maternal vital signs (e.g. heart rate, respiratory…
Read the full statement (243 words)
The ANNE® Maternal system is a perinatal monitoring platform intended for the continuous collection, display, and storage of physiological data and vital signs from compatible medical devices in clinical settings. The system supports data acquisition from sensors, clinician inputted data, and compatible software for maternal and fetal monitoring in singleton pregnancies. Examples of parameters include maternal vital signs (e.g. heart rate, respiratory rate, SpO2, blood pressure, temperature), fetal heart rate, and uterine contractions. The system provides both visual and audio alarms, alerts, and notifications at the bedside via a mobile device or a compatible central monitor. The ANNE® Maternal system is intended for use by qualified healthcare professionals. This device is intended for use by healthcare professionals to support clinical decision-making. All information provided by the system is intended to supplement, not replace, the judgement of medical professionals and is not intended to be the sole source of information for decision-making.
The physiological parameters collected by the ANNE® Maternal system is inputted into the integrated electronic Modified Early Obstetric Warning System (MEOWS) tool, which provides information that can signal the need for prompt bedside evaluation by the health care provider. This information is intended as adjunctive information only and is not intended to replace or supersede the review of individual vital signs by qualified healthcare professionals.
This information is intended to supplement, and not replace, the judgment of medical professionals and is not intended to be the sole source of information for decision-making.
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/K253021 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253021: ANNE Maternal.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253021
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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