FDA product code HGX: Pump, Breast, Powered
HGX is the FDA product code for pump, breast, powered. It is a Class II device, regulated under 21 CFR 884.5160 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 253 510(k) submissions under HGX, 108 in the last five years, from 111 different applicants. The average 510(k) review took 167 days (median 145); 156 days on average over the last three years. FDA has posted 8 recalls for HGX devices.
Classification
| Field | Value |
|---|---|
| Device name | Pump, Breast, Powered |
| Device class | Class II |
| Regulation | 21 CFR 884.5160 |
| 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 HGX
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 8 | 170 |
| 2018 | 6 | 155 |
| 2019 | 7 | 170 |
| 2020 | 9 | 139 |
| 2021 | 12 | 241 |
| 2022 | 15 | 201 |
| 2023 | 15 | 161 |
| 2024 | 19 | 176 |
| 2025 | 26 | 120 |
| 2026 | 33 | 171 |
Compare with all 510(k) review times · Search every HGX clearance
Top HGX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Shenzhen TPH Technology Co., Ltd. | 24 | 2026-09-17 |
| Shenzhen Root Innovation Technology Co., Ltd. | 10 | 2026-06-18 |
| Medela, LLC | 7 | 2026-04-10 |
| Medela, Inc. | 7 | 2016-10-28 |
| Guangdong Horigen Mother & Baby Products Co., Ltd. | 6 | 2026-09-01 |
106 more applicants have HGX clearances. See the full list in Caduvo.
Most recent HGX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K254203 | Shenzhen TPH Technology Co., Ltd. | Wearable Breast Pump (Model S36) | 2026-09-17 | 262 |
| K261622 | Philips Consumer Lifestyle B.V. | Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model: SCF593/52, SCF593/62); Philips Avent Natural Care Warming Hands-free Wearable Electric Breast Pump (Model: SCF594/52, SCF594/62) | 2026-09-03 | 111 |
| K262774 | Guangdong Horigen Mother & Baby Products Co., Ltd. | Wearable breast pump (Model: XN/MD-2249BS, ZFHF) | 2026-09-01 | 28 |
| K260643 | Cimilre Co., Ltd. | Cimilre Dual Max | 2026-08-21 | 175 |
| K261298 | Guangdong Youmeng Electrical Technology Co., Ltd. | Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42)) | 2026-08-20 | 122 |
Recalls for HGX devices
8 product recalls in 5 recall events; 0 initiated in the last five years and 1 still open. Most recent: 2017-07-10.
| Year | Recalls |
|---|---|
| 2017 | 1 |
Frequently asked questions
What is FDA product code HGX?
HGX is the FDA product code for pump, breast, powered. It is a Class II device, regulated under 21 CFR 884.5160 and reviewed by the Obstetrics and Gynecology panel.
What device class is HGX?
Class II, regulation 21 CFR 884.5160. Typical premarket route: 510(k).
How long does a 510(k) take for product code HGX?
Across 253 cleared submissions the average was 167 days from receipt to decision (median 145).
Which companies have the most HGX clearances?
Shenzhen TPH Technology Co., Ltd. (24); Shenzhen Root Innovation Technology Co., Ltd. (10); Medela, LLC (7); Medela, Inc. (7); Guangdong Horigen Mother & Baby Products Co., Ltd. (6).
Have HGX devices been recalled?
Yes: 8 product recalls across 5 recall events; the most recent began 2017-07-10.
Next steps
- Run an FDA pathway report with predicate devices for product code HGX
- Run a recall and safety report across every HGX manufacturer
- Watch product code HGX 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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