Wearable Breast Pump (Model S21A)— 510(k) K260033
Substantially EquivalentShenzhen TPH Technology Co., Ltd.
FDA 510(k) clearance K260033 for Wearable Breast Pump (Model S21A), Substantially Equivalent on 2026-04-08. Applicant: Shenzhen TPH Technology Co., Ltd.. Device class: 2.
Summary
The Wearable Breast Pump (Model S21A) is a powered breast pump under HGX. It has no brand name in the record. Generic names like this often belong to OEM products sold under other companies' labels, though the record doesn't say so here.
Class II, 21 CFR 884.5160. The Obstetrics and Gynecology panel reviewed it as a Traditional 510(k).
Shenzhen TPH Technology filed from Shenzhen, China. Review took 92 days (January 6 to April 8, 2026).
Clearance details
- Applicant
- Shenzhen TPH Technology Co., Ltd.
- Product code
- Code HGX
- Device class
- Class 2
- Regulation
- 21 CFR 884.5160
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shenzhen, CN
Recent devices under product code HGX
view all- K261622 — Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model: SCF593/52, SCF593/62) +1 more
- K262774 — Wearable breast pump (Model: XN/MD-2249BS, ZFHF)
- K260643 — Cimilre Dual Max
- K261298 — Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42))
- K260259 — DiscreetDuo Flow Wearable Breast Pump (Model S3)
More clearances from Shenzhen TPH Technology Co., Ltd.
view allAdverse events under product code HGX
product code HGX- Injury
- 758
- Other
- 2
- Total
- 760
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.