510(k) · Cleared
ClearedMedi-Trace (R) Fetal Monitoring Spiral Electrode
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Graphic Controls Corp. · HGP Electrode, Circular (Spiral), Scalp And Applicator
Cleared on Jan 29, 1991 after a 103-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 8 later devices descend from it.
- Decided
- Jan 29, 1991
- Review
- 103 days
- Class
- Class II
- Product code
- HGP
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 1 citing it directly.
- This deviceK904745 Medi-Trace (R) Fetal Monitoring Spiral ElectrodeGraphic Controls Corp. · 1991
- Descendant · cites it directly · 7 of its ownK030691 Fetal Spiral Electrode, Model FSE07000Clinical Innovations, Inc. · 2003 · Recalled
- Descendant · 2 generations on · 5 of its ownK080672 BirthtrackBarnev, Ltd. · 2008
- Descendant · 3 generations on · 4 of its ownK082704 Birthtrack (a.K.a. CLM)Barnev, Ltd. · 2009
- Descendant · 4 generations on · 3 of its ownK103172 Civ-OB (Plus)Civnet Communication, Ltd. · 2011
- Descendant · 5 generations on · 1 of its ownK143695 Central Monitoring SystemEdan Instruments, Inc. · 2015
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K030691Fetal Spiral Electrode, Model FSE07000Clinical Innovations, Inc. · 2003 · cites it directly7descendants
- K080672BirthtrackBarnev, Ltd. · 2008 · 2 generations on5descendants
- K082704Birthtrack (a.K.a. CLM)Barnev, Ltd. · 2009 · 3 generations on4descendants
- K103172Civ-OB (Plus)Civnet Communication, Ltd. · 2011 · 4 generations on3descendants
- K143695Central Monitoring SystemEdan Instruments, Inc. · 2015 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K904745 | Medi-Trace (R) Fetal Monitoring Spiral Electrode | Graphic Controls Corp. | 1991 | — |
| +1 | K030691 | Fetal Spiral Electrode, Model FSE07000 | Clinical Innovations, Inc. | 2003 | 2 |
| +2 | K080672 | Birthtrack | Barnev, Ltd. | 2008 | — |
| +3 | K082704 | Birthtrack (a.K.a. CLM) | Barnev, Ltd. | 2009 | — |
| +4 | K103172 | Civ-OB (Plus) | Civnet Communication, Ltd. | 2011 | — |
| +5 | K143695 | Central Monitoring System | Edan Instruments, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 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 HGP? 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 HGP device
- #1 K243291 Goldtrace Fetal Spiral Electrode (FSE)…score 9.0 · 2 generations · no Class I recall
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? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K030691 | Fetal Spiral Electrode, Model FSE07000 | 2003 | 7 |
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, K030691 (Clinical Innovations, Inc., 2003) has gone furthest, with 7 descendants of its own.
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.
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 | — |
https://510kreport.com/device/K904745 · printed Nov 4, 2026
Cite this page
510(k) Report. “K904745: Medi-Trace (R) Fetal Monitoring Spiral Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K904745
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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