FDA product code HGP: Electrode, Circular (Spiral), Scalp And Applicator
HGP is the FDA product code for electrode, circular (spiral), scalp and applicator. It is a Class II device, regulated under 21 CFR 884.2675 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 17 510(k) submissions under HGP, 1 in the last five years, from 13 different applicants. The average 510(k) review took 113 days (median 91); 91 days on average over the last three years. FDA has posted 3 recalls for HGP devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Electrode, Circular (Spiral), Scalp And Applicator |
| Device class | Class II |
| Regulation | 21 CFR 884.2675 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for HGP
| Year | Clearances | Avg. review days |
|---|---|---|
| 2025 | 1 | 91 |
Compare with all 510(k) review times · Search every HGP clearance
Top HGP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Graphic Controls Corp. | 3 | 1994-10-20 |
| Clinical Innovations, Inc. | 2 | 2003-09-17 |
| Medical Accessories, Inc. | 2 | 1990-04-04 |
| Neoventa Medical AB | 1 | 2025-01-17 |
| Neward Enterprises, Inc. | 1 | 1991-12-10 |
8 more applicants have HGP clearances. See the full list in Caduvo.
Most recent HGP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K243291 | Neoventa Medical AB | Goldtrace Fetal Spiral Electrode (FSE) (CNS000004) | 2025-01-17 | 91 |
| K030691 | Clinical Innovations, Inc. | FETAL SPIRAL ELECTRODE, MODEL FSE07000 | 2003-09-17 | 196 |
| K003458 | Clinical Innovations, Inc. | SOFT BEAT FETAL HEART RATE ELECTRODE MODEL SBT-7000 | 2001-05-03 | 177 |
| K943732 | Graphic Controls Corp. | LIFE TRACE FETAL SPIRAL ELECTRODE WITH MATERNAL REFERENCE | 1994-10-20 | 79 |
| K910815 | Neward Enterprises, Inc. | CR SPIRAL ELECTRODE | 1991-12-10 | 287 |
Recalls for HGP devices
3 product recalls in 3 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2022-11-21.
| Year | Recalls |
|---|---|
| 2019 | 1 |
| 2022 | 1 |
Frequently asked questions
What is FDA product code HGP?
HGP is the FDA product code for electrode, circular (spiral), scalp and applicator. It is a Class II device, regulated under 21 CFR 884.2675 and reviewed by the Obstetrics and Gynecology panel.
What device class is HGP?
Class II, regulation 21 CFR 884.2675. Typical premarket route: 510(k).
How long does a 510(k) take for product code HGP?
Across 17 cleared submissions the average was 113 days from receipt to decision (median 91).
Which companies have the most HGP clearances?
Graphic Controls Corp. (3); Clinical Innovations, Inc. (2); Medical Accessories, Inc. (2); Neoventa Medical AB (1); Neward Enterprises, Inc. (1).
Have HGP devices been recalled?
Yes: 3 product recalls across 3 recall events; the most recent began 2022-11-21.
Next steps
- Run an FDA pathway report with predicate devices for product code HGP
- Run a recall and safety report across every HGP manufacturer
- Watch product code HGP for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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