510(k) · Cleared
ClearedGoldtrace Fetal Spiral Electrode (FSE) (CNS000004)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neoventa Medical AB · HGP Electrode, Circular (Spiral), Scalp And Applicator
Cleared on Jan 17, 2025 as substantially equivalent to K030691 (Clinical Innovations, Inc., 2003) after a 91-day review. Its family tree reaches back 2 generations to 1977.
- Decided
- Jan 17, 2025
- Review
- 91 days
- Class
- Class II
- Product code
- HGP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K771553 (1977). 7 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 | K771553 | Spiral Scalp Electrode, 14499A | Hewlett-Packard Co. | 1977 | — |
| −1 | K030691 | Fetal Spiral Electrode, Model FSE07000 | Clinical Innovations, Inc. | 2003 | 2 |
| 0 (this device) | K243291 | Goldtrace Fetal Spiral Electrode (FSE) (CNS000004) | Neoventa Medical AB | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1985 | 1 | 0 |
| 1987 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 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 HGP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K030691 | Fetal Spiral Electrode, Model FSE07000Summary page 5…cator) Classification Panel: Obstetrics/Gynecology III. PREDICATE DEVICE Device Name: Fetal Spiral Electrode Manufacturer: Clinical Innovations, Inc 510(k) Number: K030691 The predicate device has not been subject to a design-related recall. IV. DEVICE DESCRIPTION Goldtrace FSE is a sterile,… | 2003 |
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 48 years and passes through 3 companies; a new generation was cleared every 26.1 years on median.
- 2 of the 7 ancestors have a recall of any class.
- 1 other device also cites its predicate K030691.
How does its category compare?
All HGP devicesHGP Electrode, Circular (Spiral), Scalp And Applicator: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · HGP
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HGP
Too few HGP 510(k)s in any year since 2007 to give a median.
Recalls per year · HGP
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HGP
6in 2024
MAUDE reports naming product code HGP, 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 | 0 | — | 0 | 12 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 4 |
| 2010 | 0 | — | 0 | 5 |
| 2011 | 0 | — | 0 | 2 |
| 2012 | 0 | — | 1 | 4 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 0 | — | 0 | 10 |
| 2016 | 0 | — | 0 | 3 |
| 2017 | 0 | — | 0 | 17 |
| 2018 | 0 | — | 0 | 44 |
| 2019 | 0 | — | 0 | 26 |
| 2020 | 0 | — | 0 | 25 |
| 2021 | 0 | — | 0 | 33 |
| 2022 | 0 | — | 1 | 27 |
| 2023 | 0 | — | 0 | 8 |
| 2024 | 0 | — | 0 | 6 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Goldtrace FSE is indicated for patients requiring continuous electronic intrapartum monitoring of the fetal heart rate during labor and delivery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243291 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243291: Goldtrace Fetal Spiral Electrode (FSE) (CNS000004).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243291
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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