510(k) · Cleared
ClearedSonicaid FM820, Sonicaid FM830
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oxford Instruments · HGM System, Monitoring, Perinatal
Cleared on Mar 9, 2001 after a 235-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 18 later devices descend from it.
- Decided
- Mar 9, 2001
- Review
- 235 days
- Class
- Class II
- Product code
- HGM
- Recalls
- None
- Predicates
- 0
18 later devices descend from it, 2 citing it directly.
- This deviceK002150 Sonicaid FM820, Sonicaid FM830Oxford Instruments · 2001
- Descendant · cites it directly · 12 of its ownK040903 Cadence, Models 2001 and 2002Edan Instruments, Inc. · 2004
- Descendant · 2 generations on · 11 of its ownK073221 Cadence IIEdan Instruments, Inc. · 2007
- Descendant · 3 generations on · 6 of its ownK082602 Fetal & Maternal Monitor, Model F6, F9Edan Instruments, Inc. · 2008
- Descendant · 4 generations on · 5 of its ownK100797 Fetal Maternal Monitor Model F9 Express and ExpressEdan Instruments, Inc. · 2010
- Descendant · cites it directly · 4 of its ownK090285 Sonicaid FM820 and FM830 EncoreHuntleigh Healthcare, Ltd. · 2009
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K040903Cadence, Models 2001 and 2002Edan Instruments, Inc. · 2004 · cites it directly12descendants
- K073221Cadence IIEdan Instruments, Inc. · 2007 · 2 generations on11descendants
- K082602Fetal & Maternal Monitor, Model F6, F9Edan Instruments, Inc. · 2008 · 3 generations on6descendants
- K100797Fetal Maternal Monitor Model F9 Express and ExpressEdan Instruments, Inc. · 2010 · 4 generations on5descendants
- K090285Sonicaid FM820 and FM830 EncoreHuntleigh Healthcare, Ltd. · 2009 · cites it directly4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K002150 | Sonicaid FM820, Sonicaid FM830 | Oxford Instruments | 2001 | — |
| +1 | K040903 | Cadence, Models 2001 and 2002 | Edan Instruments, Inc. | 2004 | — |
| +2 | K073221 | Cadence II | Edan Instruments, Inc. | 2007 | — |
| +3 | K082602 | Fetal & Maternal Monitor, Model F6, F9 | Edan Instruments, Inc. | 2008 | — |
| +4 | K100797 | Fetal Maternal Monitor Model F9 Express and Express | Edan Instruments, Inc. | 2010 | — |
| +1 | K090285 | Sonicaid FM820 and FM830 Encore | Huntleigh Healthcare, Ltd. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (18)
See all 182 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?
- Of its descendants, K040903 (Edan Instruments, Inc., 2004) has gone furthest, with 12 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 | — |
https://510kreport.com/device/K002150 · printed Nov 6, 2026
Cite this page
510(k) Report. “K002150: Sonicaid FM820, Sonicaid FM830.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002150
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026