510(k) · Cleared
ClearedBaby Dopplex 3000 MK 2 (BD3000)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Huntleigh Healthcare, Inc. · HGM System, Monitoring, Perinatal
Cleared on Apr 25, 2001 after a 30-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 24 later devices descend from it.
- Decided
- Apr 25, 2001
- Review
- 30 days
- Class
- Class II
- Product code
- HGM
- Recalls
- None
- Predicates
- 0
24 later devices descend from it, 2 citing it directly.
- This deviceK010889 Baby Dopplex 3000 MK 2 (BD3000)Huntleigh Healthcare, Inc. · 2001
- Descendant · cites it directly · 21 of its ownK040480 Sonotrax Ultrasonic Pocket DopplerEdan Instruments, Inc. · 2004
- Descendant · 2 generations on · 13 of its ownK080087 Sonotrax Ultrasonic Fetal and Vascular Pocket Doppler, Models Lite…Edan Instruments, Inc. · 2008
- Descendant · 3 generations on · 7 of its ownK092997 Ultrasonic Tabletop Doppler, Models SD5 and SD6Edan Instruments, Inc. · 2009
- Descendant · 3 generations on · 5 of its ownK102138 Ultrasonic Tabletop Doppler; Ultrasonic Tabletop DopplerEdan Instruments, Inc. · 2010
- Descendant · 4 generations on · 4 of its ownK153475 SD5 & SD6 Ultrasonic Tabletop DopplerEdan Instruments, Inc. · 2016
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K040480Sonotrax Ultrasonic Pocket DopplerEdan Instruments, Inc. · 2004 · cites it directly21descendants
- K080087Sonotrax Ultrasonic Fetal and Vascular Pocket Doppler, Models Lite, Basic, Pro, II, II…Edan Instruments, Inc. · 2008 · 2 generations on13descendants
- K092997Ultrasonic Tabletop Doppler, Models SD5 and SD6Edan Instruments, Inc. · 2009 · 3 generations on7descendants
- K102138Ultrasonic Tabletop Doppler; Ultrasonic Tabletop DopplerEdan Instruments, Inc. · 2010 · 3 generations on5descendants
- K153475SD5 & SD6 Ultrasonic Tabletop DopplerEdan Instruments, Inc. · 2016 · 4 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K010889 | Baby Dopplex 3000 MK 2 (BD3000) | Huntleigh Healthcare, Inc. | 2001 | — |
| +1 | K040480 | Sonotrax Ultrasonic Pocket Doppler | Edan Instruments, Inc. | 2004 | — |
| +2 | K080087 | Sonotrax Ultrasonic Fetal and Vascular Pocket Doppler, Models Lite, Basic… | Edan Instruments, Inc. | 2008 | — |
| +3 | K092997 | Ultrasonic Tabletop Doppler, Models SD5 and SD6 | Edan Instruments, Inc. | 2009 | — |
| +3 | K102138 | Ultrasonic Tabletop Doppler; Ultrasonic Tabletop Doppler | Edan Instruments, Inc. | 2010 | — |
| +4 | K153475 | SD5 & SD6 Ultrasonic Tabletop Doppler | Edan Instruments, Inc. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 4 | 0 |
| 2011 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (24)
See all 242 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, K040480 (Edan Instruments, Inc., 2004) has gone furthest, with 21 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/K010889 · printed Nov 6, 2026
Cite this page
510(k) Report. “K010889: Baby Dopplex 3000 MK 2 (BD3000).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010889
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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