510(k) · Cleared
ClearedDopplex Centrale
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Huntleigh Healthcare, Ltd. · HGM System, Monitoring, Perinatal
Cleared on Mar 23, 2006 as substantially equivalent to K970456 (Hewlett-Packard GmbH, 1997) after a 52-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- Mar 23, 2006
- Review
- 52 days
- Class
- Class II
- Product code
- HGM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K970456 (1997). No later device cites it as a predicate yet.
- Root · 1 generation backK970456 Hewlett Apckard Series 50 OB Tracevue Obstetrical Surveillance and…Hewlett-Packard GmbH · 1997
- This deviceK060230 Dopplex CentraleHuntleigh Healthcare, Ltd. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K970456 | Hewlett Apckard Series 50 OB Tracevue Obstetrical Surveillance and Archiving… | Hewlett-Packard GmbH | 1997 | — |
| 0 (this device) | K060230 | Dopplex Centrale | Huntleigh Healthcare, Ltd. | 2006 | — |
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 |
|---|---|---|---|
| * | K970456 | Hewlett Apckard Series 50 OB Tracevue Obstetrical Surveillance and Archiving SystemSummary page 2…tion Name Perinatal monitoring system and accessories Product code [HGM CFR number 884.2740 Predicate Device Philips 08 TraceVue (K970456) Formerly Hewlett Packard (Agilent) Series 5008 TraceVue… | 1997 |
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?
- Its one ancestor has no recall.
- 4 other devices also cite its predicate K970456.
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?
Dopplex Centrale (DCII) is a software package that collects and manages real-time data from a maximum of 48 individual fetal monitors which are connected to a central server by means communication links. Dopplex Centrale is indicated for use in healthcare facilities by healthcare professionals whenever there is a need for comprehensive and centralised obstetrical surveillance of those maternal patients who are being monitored by otherwise autonomous CTG…
Read the full statement (223 words)
Dopplex Centrale (DCII) is a software package that collects and manages real-time data from a maximum of 48 individual fetal monitors which are connected to a central server by means communication links.
Dopplex Centrale is indicated for use in healthcare facilities by healthcare professionals whenever there is a need for comprehensive and centralised obstetrical surveillance of those maternal patients who are being monitored by otherwise autonomous CTG devices. Fetal heart rate information can be concurrently viewed on up to 50 conveniently sited computers including a central station, patient bedsides, nurses' lounges and physicians' offices.
Dopplex Centrale provides an easy to use means of patient surveillance within a perinatal environment within a hospital. A Dopplex Centrale system is specified, supplied, commissioned and maintained exclusively by the manufacturer, Huntleigh Healthcare, or its appointed agents. It provides storage and archiving of FHR traces together with the associated patient details.
The specific medical indications for the use of this device is
* This device is a prescription device
* This device is not intended to contact the patient
* This device is used continuously in Obstetrical Departments
* Basic fetal trace alerting for antepartum and intrapartum applications
* The physiological purpose is indirect. The device is intended to gather and store fetal and maternal information provided by the attached fetal monitors which constitute the primary care sources.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060230 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060230: Dopplex Centrale.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060230
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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