# HGP: Electrode, Circular (Spiral), Scalp And Applicator

- Device class: 2; regulation: 21 CFR 884.2675; FDA's rule: 510(k) required
- FDA decisions: 17
- 510(k) review time 2021–2025: median 91 days (middle half 91–91)
- Recalls: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1980: 2
- 1983: 1
- 1985: 1
- 1987: 2
- 1990: 1
- 1991: 5
- 1994: 1
- 2001: 1
- 2003: 1
- 2025: 1

## Most-cited predicates
- K030691: Fetal Spiral Electrode, Model FSE07000 (2003), cited by 2
- K844608: Surgicraft Copeland Disposable (1985), cited by 2
- K771553: Spiral Scalp Electrode, 14499A (1977), cited by 1
- K904745: Medi-Trace (R) Fetal Monitoring Spiral Electrode (1991), cited by 1
- K872057: Fetal Scalp Electrode (1987), cited by 1
- K792669: Corometrics-Push Button Spiral Electrode (1980), cited by 1
- K943732: Life Trace Fetal Spiral Electrode with Maternal Reference (1994), cited by 1

Source page: https://510kreport.com/product-code/HGP
Data by year (CSV): https://510kreport.com/product-code/HGP.csv