Wearable Breast Pump (Model S36)— 510(k) K254203
Substantially EquivalentShenzhen TPH Technology Co., Ltd.
FDA 510(k) clearance K254203 for Wearable Breast Pump (Model S36), Substantially Equivalent on 2026-09-17. Applicant: Shenzhen TPH Technology Co., Ltd.. Device class: 2.
Summary
The Wearable Breast Pump (Model S36) is from Shenzhen TPH Technology Co., Ltd., filed under product code HGX (Pump, Breast, Powered). The record gives the model number and no other detail.
Class II, 21 CFR 884.5160. Obstetrics/Gynecology is both the classification panel and the review panel, and it came in as a Traditional 510(k). The decision was Substantially Equivalent.
Shenzhen TPH filed from Shenzhen, China. The decision came 262 calendar days after FDA received it (December 29, 2025 to September 17, 2026).
Clearance details
- Applicant
- Shenzhen TPH Technology Co., Ltd.
- Product code
- Product 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.