510(k) · Cleared
ClearedSonicaid System 8002
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oxford Instruments Medical Systems · HGM System, Monitoring, Perinatal
Cleared on Apr 27, 2001 as substantially equivalent to K912639 (Oxford Medilog, Inc., 1991) after a 633-day review. Its family tree reaches back 1 generation to 1991. 28 later devices descend from it.
- Decided
- Apr 27, 2001
- Review
- 633 days
- Class
- Class II
- Product code
- HGM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K912639 (1991). 28 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK912639 Sonicaid TeamOxford Medilog, Inc. · 1991
- This deviceK992607 Sonicaid System 8002Oxford Instruments Medical Systems · 2001
- Descendant · cites it directly · 22 of its ownK081140 VisensiaObs Medical · 2008
- Descendant · 2 generations on · 17 of its ownK110953 Visensia, Visensia with AlertObs Medical · 2011
- Descendant · 2 generations on · 16 of its ownK152258 T3 SoftwareEtiometry, Inc. · 2016
- Descendant · 3 generations on · 15 of its ownK163065 T3 SoftwareEtiometry, Inc. · 2017
- Descendant · 4 generations on · 14 of its ownK190273 T3 Platform softwareEtiometry, Inc. · 2019
Showing 5 of 28 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 28 · See all- K081140VisensiaObs Medical · 2008 · cites it directly22descendants
- K110953Visensia, Visensia with AlertObs Medical · 2011 · 2 generations on17descendants
- K152258T3 SoftwareEtiometry, Inc. · 2016 · 2 generations on16descendants
- K163065T3 SoftwareEtiometry, Inc. · 2017 · 3 generations on15descendants
- K190273T3 Platform softwareEtiometry, Inc. · 2019 · 4 generations on14descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K912639 | Sonicaid Team | Oxford Medilog, Inc. | 1991 | — |
| 0 (this device) | K992607 | Sonicaid System 8002 | Oxford Instruments Medical Systems | 2001 | — |
| +1 | K081140 | Visensia | Obs Medical | 2008 | — |
| +2 | K110953 | Visensia, Visensia with Alert | Obs Medical | 2011 | — |
| +2 | K152258 | T3 Software | Etiometry, Inc. | 2016 | — |
| +3 | K163065 | T3 Software | Etiometry, Inc. | 2017 | — |
| +4 | K190273 | T3 Platform software | Etiometry, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 5 | 0 |
| 2024 | 3 | 0 |
| 2025 | 4 | 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 |
|---|---|---|---|
| * | K912639 | Sonicaid TeamSummary page 2…, Doppler evaluations, and/or biophysical profile. 4, Substantia) Equivalence The Sonicaid® System 8002 is substantially equivalent to the Sonicaid® Team fetal monitor K912639. S. Performance Studies The Sonicaid® System 8002 informs the clinician whether a CTG meets a number of criteria that are indic… | 1991 |
What descends from it? (28)
See all 282 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?
- Its one ancestor has no recall.
- Of its descendants, K081140 (Obs Medical, 2008) has gone furthest, with 22 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 | — |
What is it indicated for?
The Sénicaid System 8002 is for use in pregnancies from 32 weeks gestation onwards. It can be used on women who are experiencing Braxton-Hicks contractions but is not suitable for use in established labour as the fetus is then exposed to additional factors such as labour contractions, pharmacological agents, epidural anaesthesia, and the possibility of fetal infection secondary to ruptured membranes. Typical indications for use include the following: —…
Read the full statement (149 words)
The Sénicaid System 8002 is for use in pregnancies from 32 weeks gestation onwards. It can be used on women who are experiencing Braxton-Hicks contractions but is not suitable for use in established labour as the fetus is then exposed to additional factors such as labour contractions, pharmacological agents, epidural anaesthesia, and the possibility of fetal infection secondary to ruptured membranes. Typical indications for use include the following:
— previous questionable fetal heart rate recordings or poor obstetric history
_ abnormal umbilical blood flow velocity waveforms
— suspected fetal anomalies
— suspicion of maternal intoxication or assault
— intrauterine growth retardation
— antepartum haemorrhage
— uterine pain
— reduced fetal movements
— hypertension or pre-eclampsia
— reduced amniotic fluid volume
The Sonicaid System 8002 is used as an adjunct to and is not intended to replace or substitute for assessment of amniotic fluid amount, Doppler evaluations, and/or biophysical profile.
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/K992607 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992607: Sonicaid System 8002.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992607
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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