HGP · Class II · 21 CFR 884.2675

FDA Product Code HGP: Electrode, Circular (spiral), Scalp And Applicator

Leading manufacturers include Graphic Controls Corp., Clinical Innovations, Inc. and Neoventa Medical AB.

17
Total
17
Cleared
113d
Avg days
1977
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times improving: avg 91d recently vs 114d historically

FDA 510(k) Cleared Electrode, Circular (spiral), Scalp And Applicator Devices (Product Code HGP)

17 devices
1–17 of 17
Cleared Jan 17, 2025
Goldtrace Fetal Spiral Electrode (FSE) (CNS000004)
K243291
Neoventa Medical AB
Obstetrics & Gynecology · 91d
Cleared May 03, 2001
SOFT BEAT FETAL HEART RATE ELECTRODE MODEL SBT-7000
K003458
Clinical Innovations, Inc.
Obstetrics & Gynecology · 177d
Cleared Oct 20, 1994
LIFE TRACE FETAL SPIRAL ELECTRODE WITH MATERNAL REFERENCE
K943732
Graphic Controls Corp.
Obstetrics & Gynecology · 79d
Cleared Mar 29, 1991
COMBO FETAL SCALP ELECTRODE/LEGPLATE
K905830
Utah Medical Products, Inc.
Obstetrics & Gynecology · 88d
Cleared Jan 29, 1991
MEDI-TRACE(R) FETAL MONITORING SPIRAL ELECTRODE
K904745
Graphic Controls Corp.
Obstetrics & Gynecology · 103d
Cleared Jan 29, 1991
FETAL MONITORING SPIRAL ELECTRODE
K905130
Graphic Controls Corp.
Obstetrics & Gynecology · 75d
Cleared Feb 24, 1983
MULTI-PRONG FETAL SCALP ELECTRODE
K822584
Kontron Instruments, Inc.
Obstetrics & Gynecology · 182d
Cleared Feb 11, 1980
COROMETRICS-PUSH BUTTON SPIRAL ELECTRODE
K792669
Ge Medical Systems Information Technologies
Obstetrics & Gynecology · 46d
Cleared Aug 25, 1977
SPIRAL SCALP ELECTRODE, 14499A
K771553
Hewlett-Packard Co.
Obstetrics & Gynecology · 13d

About Product Code HGP - Regulatory Context

510(k) Submission Activity

17 total 510(k) submissions under product code HGP since 1977, with 17 receiving FDA clearance (average review time: 113 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - HGP Product Code

Recent submissions under HGP have taken an average of 91 days to reach a decision - down from 114 days historically, suggesting improved FDA processing for this classification.

HGP devices are reviewed by the Obstetrics & Gynecology panel. Browse all Obstetrics & Gynecology devices →