# K030691: Fetal Spiral Electrode, Model FSE07000

- Pathway: 510(k) (Traditional)
- Applicant: Clinical Innovations, Inc.
- Decided: Sep 17, 2003 after 196 days
- Product code: HGP (Electrode, Circular (Spiral), Scalp And Applicator)
- Device class: 2
- Regulation: 21 CFR 884.2675
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K771553 (1977). 6 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943732: Life Trace Fetal Spiral Electrode with Maternal Reference, Graphic Controls Corp. (1994) Summary page 1.
- K792669: Corometrics-Push Button Spiral Electrode, Ge Medical Systems Information Technologies (1980) Summary page 1.
- K771553: Spiral Scalp Electrode, 14499A, Hewlett-Packard Co. (1977) Summary page 1.
- K904745: Medi-Trace (R) Fetal Monitoring Spiral Electrode, Graphic Controls Corp. (1991) Summary page 1.
- K872057: Fetal Scalp Electrode, Medical Accessories, Inc. (1987) Summary page 1.
- K844608: Surgicraft Copeland Disposable, A.W. Showell (Surgicraft), Ltd. (1985) Summary page 1.

## Most influential descendants
- K080672: Birthtrack (2008), 5 descendants of its own
- K082704: Birthtrack (a.K.a. CLM) (2009), 4 descendants of its own
- K103172: Civ-OB (Plus) (2011), 3 descendants of its own
- K143695: Central Monitoring System (2015), 1 descendant of its own
- K243291: Goldtrace Fetal Spiral Electrode (FSE) (CNS000004) (2025), 0 descendants of its own

## Recalls of this device
- Nov 21, 2022 · Class II · Z-0908-2023: Fetal 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
- Jan 25, 2019 · Class II · Z-1250-2019: During 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.

## Indications for use
For patients requiring fetal heart rate monitoring during labor.

Source page: https://510kreport.com/device/K030691
Methodology: https://510kreport.com/methodology