FDA product code HGM: System, Monitoring, Perinatal
HGM is the FDA product code for system, monitoring, perinatal. It is a Class II device, regulated under 21 CFR 884.2740 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 215 510(k) submissions under HGM, 10 in the last five years, from 94 different applicants. The average 510(k) review took 146 days (median 93); 248 days on average over the last three years. FDA has posted 28 recalls for HGM devices, 6 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | System, Monitoring, Perinatal |
| Device class | Class II |
| Regulation | 21 CFR 884.2740 |
| 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 HGM
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 3 | 129 |
| 2018 | 3 | 245 |
| 2020 | 1 | 72 |
| 2022 | 1 | 101 |
| 2023 | 2 | 176 |
| 2024 | 1 | 258 |
| 2025 | 4 | 288 |
| 2026 | 2 | 198 |
Compare with all 510(k) review times · Search every HGM clearance
Top HGM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ge Medical Systems Information Technologies | 28 | 2005-06-21 |
| Edan Instruments, Inc. | 12 | 2025-08-27 |
| Hewlett-Packard Co. | 11 | 1994-08-15 |
| Advantage Medical Systems, Inc. | 9 | 1986-07-07 |
| Philips Medizin Systeme Boeblingen GmbH | 7 | 2024-07-02 |
89 more applicants have HGM clearances. See the full list in Caduvo.
Most recent HGM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K254036 | Datex Ohmeda, Inc. | Novii+ Wireless Patch System | 2026-08-10 | 237 |
| K253021 | Sibel Health, Inc. | ANNE Maternal | 2026-02-26 | 160 |
| K250777 | Huntleigh Healthcare , Ltd. | Sonicaid Team3 | 2025-09-19 | 189 |
| K241882 | Edan Instruments, Inc. | Fetal & Maternal Monitor (F15A, F15A Air) | 2025-08-27 | 425 |
| K241368 | Huntleigh Healthcare , Ltd. | Sonicaid Team3 | 2025-02-03 | 265 |
Recalls for HGM devices
28 product recalls in 16 recall events; 6 initiated in the last five years and 11 still open. Most recent: 2026-05-26.
| Year | Recalls |
|---|---|
| 2019 | 5 |
| 2024 | 1 |
| 2025 | 3 |
| 2026 | 2 |
Frequently asked questions
What is FDA product code HGM?
HGM is the FDA product code for system, monitoring, perinatal. It is a Class II device, regulated under 21 CFR 884.2740 and reviewed by the Obstetrics and Gynecology panel.
What device class is HGM?
Class II, regulation 21 CFR 884.2740. Typical premarket route: 510(k).
How long does a 510(k) take for product code HGM?
Across 215 cleared submissions the average was 146 days from receipt to decision (median 93).
Which companies have the most HGM clearances?
Ge Medical Systems Information Technologies (28); Edan Instruments, Inc. (12); Hewlett-Packard Co. (11); Advantage Medical Systems, Inc. (9); Philips Medizin Systeme Boeblingen GmbH (7).
Have HGM devices been recalled?
Yes: 28 product recalls across 16 recall events; the most recent began 2026-05-26.
Next steps
- Run an FDA pathway report with predicate devices for product code HGM
- Run a recall and safety report across every HGM manufacturer
- Watch product code HGM 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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