510(k) · Cleared
ClearedSurgicraft Copeland Disposable
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
A.W. Showell (Surgicraft), Ltd. · HGP Electrode, Circular (Spiral), Scalp And Applicator
Cleared on May 1, 1985 after a 155-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
- May 1, 1985
- Review
- 155 days
- Class
- Class II
- Product code
- HGP
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 2 citing it directly.
- This deviceK844608 Surgicraft Copeland DisposableA.W. Showell (Surgicraft), Ltd. · 1985
- Descendant · cites it directly · 7 of its ownK030691 Fetal Spiral Electrode, Model FSE07000Clinical Innovations, Inc. · 2003 · Recalled
- Descendant · cites it directly · 5 of its ownK080672 BirthtrackBarnev, Ltd. · 2008
- Descendant · 2 generations on · 4 of its ownK082704 Birthtrack (a.K.a. CLM)Barnev, Ltd. · 2009
- Descendant · 3 generations on · 3 of its ownK103172 Civ-OB (Plus)Civnet Communication, Ltd. · 2011
- Descendant · 4 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 · cites it directly5descendants
- K082704Birthtrack (a.K.a. CLM)Barnev, Ltd. · 2009 · 2 generations on4descendants
- K103172Civ-OB (Plus)Civnet Communication, Ltd. · 2011 · 3 generations on3descendants
- K143695Central Monitoring SystemEdan Instruments, Inc. · 2015 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K844608 | Surgicraft Copeland Disposable | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| +1 | K030691 | Fetal Spiral Electrode, Model FSE07000 | Clinical Innovations, Inc. | 2003 | 2 |
| +1 | K080672 | Birthtrack | Barnev, Ltd. | 2008 | — |
| +2 | K082704 | Birthtrack (a.K.a. CLM) | Barnev, Ltd. | 2009 | — |
| +3 | K103172 | Civ-OB (Plus) | Civnet Communication, Ltd. | 2011 | — |
| +4 | 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)
2 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, 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/K844608 · printed Nov 5, 2026
Cite this page
510(k) Report. “K844608: Surgicraft Copeland Disposable.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K844608
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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