510(k) · Cleared
ClearedBaby Dopplex 4000, Model BD 4000
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 Jan 24, 2000 as substantially equivalent to K963711 (Huntleigh Healthcare, Inc., 1997) and 2 other predicates after a 335-day review. Its family tree reaches back 2 generations to 1993.
- Decided
- Jan 24, 2000
- Review
- 335 days
- Class
- Class II
- Product code
- HGM
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K921957 (1993). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K921957 | Hewlett-Packard Model M1351A Fetal Monitor | Hewlett-Packard Co. | 1993 | — |
| −1 | K963711 | Baby Dopplex (3000) | Huntleigh Healthcare, Inc. | 1997 | — |
| 0 (this device) | K990569 | Baby Dopplex 4000, Model BD 4000 | Huntleigh Healthcare, Inc. | 2000 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 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? (3)
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 |
|---|---|---|---|
| * | K963711 | Baby Dopplex (3000)Summary page 1…ate summary prepared: 01 December 1999 Classification Name Fetal Ultrasonic Monitor and Accessories (21 CFR § 884.2660) Predicate Devices Baby Dopplex 3000 (ABD3000) K963711. Hewlett Packard GmbH’s Series 50 range of Fetal Monitors Model N°s M1351A & M1353A (K921957 & K921956 respectively). === Page 2… | 1997 |
| * | K921957 | Hewlett-Packard Model M1351A Fetal MonitorSummary page 1…essories (21 CFR § 884.2660) Predicate Devices Baby Dopplex 3000 (ABD3000) K963711. Hewlett Packard GmbH’s Series 50 range of Fetal Monitors Model N°s M1351A & M1353A (K921957 & K921956 respectively). L a4 D SiA paqe ze{z Device Description The BD4000 is a fetal monitor, which produces… | 1993 |
| * | K921956 | Hewlett Packard Model M1353A Fetal MonitorSummary page 1…21 CFR § 884.2660) Predicate Devices Baby Dopplex 3000 (ABD3000) K963711. Hewlett Packard GmbH’s Series 50 range of Fetal Monitors Model N°s M1351A & M1353A (K921957 & K921956 respectively). L a4 D SiA paqe ze{z Device Description The BD4000 is a fetal monitor, which produces cardiotoco… | 1993 |
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 7 years and passes through 2 companies; a new generation was cleared every 4.0 years on median.
- None of the 3 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.
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 Baby Dopplex® 4000 is a fetal monitor, which produces CTG’s and gives indication of uterine activity by processing received ultrasound/electrical signals.
In basic format, the device performs antepartum fetal monitoring and uterine activity functions.
Connecting separate modules to the Baby Dopplex® 4000 main unit allows it to perform Intrapartum monitoring operations.
In instances of twin presentations, two basic Baby Dopplex® 4000 units can be linked together so that both fetuses can be monitored simultaneously.
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/K990569 · printed Nov 6, 2026
Cite this page
510(k) Report. “K990569: Baby Dopplex 4000, Model BD 4000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990569
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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