510(k) Report

510(k) · Cleared

Recalled · Class II · 2022

Fetal Spiral Electrode, Model FSE07000

K030691510(k) TraditionalCleared Sep 17, 2003196-day reviewClass II21 CFR 884.2675Recalls 2

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Clinical Innovations, Inc. · HGP Electrode, Circular (Spiral), Scalp And Applicator

Cleared on Sep 17, 2003 as substantially equivalent to K943732 (Graphic Controls Corp., 1994) and 5 other predicates after a 196-day review. Its family tree reaches back 1 generation to 1977. 7 later devices descend from it. It has been recalled 2 times.

Decided
Sep 17, 2003
Review
196 days
Class
Class II
Product code
HGP
Recalls
2
Predicates
6

Its longest line of descent runs back 1 generation to K771553 (1977). 6 ancestors in all. 7 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1994: 1 other ancestor1991: 1 other ancestor1987: 1 other ancestor1985: 1 other ancestor1980: 1 other ancestor2008: 1 descendant cleared2025: 1 descendant cleared2009: 1 descendant cleared2011: 1 descendant cleared2016: 1 descendant cleared2015: 1 descendant cleared2017: 1 descendant clearedK771553 · Spiral Scalp Electrode, 14499A · Hewlett-Packard Co. · 197719801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors 1 generation forward: 2 descendants2 generations forward: 1 descendant3 generations forward: 1 descendant4 generations forward: 2 descendants5 generations forward: 1 descendant K771553 · Spiral Scalp Electrode, 14499A · Hewlett-Packard Co. · 19770+5
  1. Root · 1 generation backK771553 Spiral Scalp Electrode, 14499AHewlett-Packard Co. · 1977
  2. This deviceK030691 Fetal Spiral Electrode, Model FSE07000Clinical Innovations, Inc. · 2003
  3. Descendant · cites it directly · 5 of its ownK080672 BirthtrackBarnev, Ltd. · 2008
  4. Descendant · 2 generations on · 4 of its ownK082704 Birthtrack (a.K.a. CLM)Barnev, Ltd. · 2009
  5. Descendant · 3 generations on · 3 of its ownK103172 Civ-OB (Plus)Civnet Communication, Ltd. · 2011
  6. Descendant · 4 generations on · 1 of its ownK143695 Central Monitoring SystemEdan Instruments, Inc. · 2015
  7. Descendant · cites it directly · 0 of its ownK243291 Goldtrace Fetal Spiral Electrode (FSE) (CNS000004)Neoventa Medical AB · 2025

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2008: 12009: 12011: 12015: 12016: 12017: 12025: 1
2008high 1 (2008) · low 0 (2010)2026

Most influential descendants

Showing 5 of 7 · See all
  • 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
  • K243291Goldtrace Fetal Spiral Electrode (FSE) (CNS000004)Neoventa Medical AB · 2025 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K771553Spiral Scalp Electrode, 14499AHewlett-Packard Co.1977—
0 (this device)K030691Fetal Spiral Electrode, Model FSE07000Clinical Innovations, Inc.2003—
+1K080672BirthtrackBarnev, Ltd.2008—
+2K082704Birthtrack (a.K.a. CLM)Barnev, Ltd.2009—
+3K103172Civ-OB (Plus)Civnet Communication, Ltd.2011—
+4K143695Central Monitoring SystemEdan Instruments, Inc.2015—
+1K243291Goldtrace Fetal Spiral Electrode (FSE) (CNS000004)Neoventa Medical AB2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198010
198510
198710
199110
199410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
200910
201110
201510
201610
201710
202510
FIG. 1 — Lineage of K030691, 1977–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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.

Top candidate predicates for a new HGP device

  1. #1 K243291 Goldtrace Fetal Spiral Electrode (FSE)…score 9.0 · 2 generations · no Class I recall
Get a 510(k) Report

What was it cleared against? (6)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K943732Life Trace Fetal Spiral Electrode with Maternal Reference
Summary page 1
…ation Name: Fetal Scalp Circular Electrode and applicator The legally marketed devices to which equivalence is claimed are: Life Trace Fetal Spiral Electrode (K943732), Corometrics Spiral Electrode (K792669), HP Spiral Scalp Electrode (K771553),Medi-Trace Fetal Monitoring Spiral Electrode (K9047…
Graphic Controls Corp.1994—
*K792669Corometrics-Push Button Spiral Electrode
Summary page 1
…ar Electrode and applicator The legally marketed devices to which equivalence is claimed are: Life Trace Fetal Spiral Electrode (K943732), Corometrics Spiral Electrode (K792669), HP Spiral Scalp Electrode (K771553),Medi-Trace Fetal Monitoring Spiral Electrode (K904745),MAI Fetal Scalp Electrode (K872057),…
Ge Medical Systems Information Technologies19801
*K771553Spiral Scalp Electrode, 14499A
Summary page 1
…lly marketed devices to which equivalence is claimed are: Life Trace Fetal Spiral Electrode (K943732), Corometrics Spiral Electrode (K792669), HP Spiral Scalp Electrode (K771553),Medi-Trace Fetal Monitoring Spiral Electrode (K904745),MAI Fetal Scalp Electrode (K872057), Surgicraft Copeland Disposable (K844…
Hewlett-Packard Co.1977—
*K904745Medi-Trace (R) Fetal Monitoring Spiral Electrode
Summary page 1
…e: Life Trace Fetal Spiral Electrode (K943732), Corometrics Spiral Electrode (K792669), HP Spiral Scalp Electrode (K771553),Medi-Trace Fetal Monitoring Spiral Electrode (K904745),MAI Fetal Scalp Electrode (K872057), Surgicraft Copeland Disposable (K844608). Description of the device: The device consists o…
Graphic Controls Corp.1991—
*K872057Fetal Scalp Electrode
Summary page 1
…(K943732), Corometrics Spiral Electrode (K792669), HP Spiral Scalp Electrode (K771553),Medi-Trace Fetal Monitoring Spiral Electrode (K904745),MAI Fetal Scalp Electrode (K872057), Surgicraft Copeland Disposable (K844608). Description of the device: The device consists of a stainless steel spiral needle el…
Medical Accessories, Inc.1987—
*K844608Surgicraft Copeland Disposable
Summary page 1
…K792669), HP Spiral Scalp Electrode (K771553),Medi-Trace Fetal Monitoring Spiral Electrode (K904745),MAI Fetal Scalp Electrode (K872057), Surgicraft Copeland Disposable (K844608). Description of the device: The device consists of a stainless steel spiral needle electrode. It is fixed to the fetal scalp by…
A.W. Showell (Surgicraft), Ltd.1985—

What descends from it? (7)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K080672BirthtrackBarnev, Ltd.20085
K243291Goldtrace Fetal Spiral Electrode (FSE) (CNS000004)Neoventa Medical AB20250

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Nov 21, 2022Class IIZ-0908-2023Under Investigation by firmFetal Spiral Electrode (FSE) spiral tip of the FSE breaking off during use and requiring surgical intervention to remove the broken tip from the neonate patient. Philips has decided to discontinue the distribution of this product.
Jan 25, 2019Class IIZ-1250-2019Under Investigation by firmDuring use of the Philips FSE, it is possible for the metal electrode tip to break off and remain in the scalp of the newborn following labor and delivery.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • 1 of the 6 ancestors has a recall of any class.
  • Of its descendants, K080672 (Barnev, Ltd., 2008) has gone furthest, with 5 descendants of its own.

How does its category compare?

All HGP devices

HGP 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

2025: 1
2007high 1 (2025) · low 0 (2007)2026

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

2012: 12022: 1
2007high 1 (2012) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HGP

6in 2024

2007: 122009: 42010: 52011: 22012: 42013: 22014: 32015: 102016: 32017: 172018: 442019: 262020: 252021: 332022: 272023: 82024: 6
2007high 44 (2018) · low 0 (2008)2025

MAUDE reports naming product code HGP, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—012
20080—00
20090—04
20100—05
20110—02
20120—14
20130—02
20140—03
20150—010
20160—03
20170—017
20180—044
20190—026
20200—025
20210—033
20220—127
20230—08
20240—06
20251—00
20260—0—

What is it indicated for?

For patients requiring fetal heart rate monitoring during labor.

Indications for use as stated in the FDA summary.

More from Clinical Innovations, Inc.

9 FDA decisions under this applicant name. See the company

  • K022023Compass Esophageal Pressure Catheter, Model Gie-8500, Compass Ano-Rectal Pressure Catheter, Model Gia-8500Clinical Innovations, Inc. · 2003
  • K003458Soft Beat Fetal Heart Rate Electrode Model SBT-7000Clinical Innovations, Inc. · 2001
  • K981260Kiwi Soft Cup with Palm Pump Model Number Vfe-6000S, Kiwi Mushroom Cup with Palm Pump Model Vfe-6000MClinical Innovations, Inc. · 19982 recalls
  • K974563Colpo Cup CVC-2000Clinical Innovations, Inc. · 1998
  • K974389Koala Intrauterine Pressure Catheter, Koala External Intrauterine Pressure CatheterClinical Innovations, Inc. · 1998

Recent decisions in HGP

The HGP category page

  • K243291Goldtrace Fetal Spiral Electrode (FSE) (CNS000004)Neoventa Medical AB · 2025
  • K003458Soft Beat Fetal Heart Rate Electrode Model SBT-7000Clinical Innovations, Inc. · 2001
  • K943732Life Trace Fetal Spiral Electrode with Maternal ReferenceGraphic Controls Corp. · 1994
  • K910815CR Spiral ElectrodeNeward Enterprises, Inc. · 1991
  • K911657Fetal Scalp Spiral ElectrodeAdvanced Medical Systems, Inc. · 1991

https://510kreport.com/device/K030691 · printed Nov 6, 2026

Cite this page

510(k) Report. “K030691: Fetal Spiral Electrode, Model FSE07000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030691

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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