Shenzhen TPH Technology Co., Ltd.: FDA filings under this applicant name
FDA lists 24 510(k) clearances under the applicant name “Shenzhen TPH Technology Co., Ltd.” (first 2022, latest 2026), across 1 product code in 1 review panel. Median 510(k) review time under this name: 138 days. Since 2017 the median was 138 days, against 151 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2022 | 2 | 150 |
| 2023 | 2 | 188 |
| 2024 | 1 | 126 |
| 2025 | 11 | 109 |
| 2026 | 8 | 160 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Shenzhen TPH Technology Co., Ltd. took a median 138 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 151 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HGX | Pump, Breast, Powered | 24 | 24 |
Review panels
Most recent Shenzhen TPH Technology Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K254203 | Wearable Breast Pump (Model S36) | HGX | 2026-09-17 | 262 |
| K260259 | DiscreetDuo Flow Wearable Breast Pump (Model S3) | HGX | 2026-07-24 | 177 |
| K261199 | Wearable Breast Pump (Model S32A) | HGX | 2026-07-13 | 91 |
| K260864 | Mother's Nature W1 Warming Wearable Breast Pump | HGX | 2026-06-09 | 84 |
| K254244 | Wearable Breast Pump (Model S39) | HGX | 2026-05-21 | 143 |
| K260033 | Wearable Breast Pump (Model S21A) | HGX | 2026-04-08 | 92 |
| K252422 | Wearable Breast Pump (Model W2) | HGX | 2026-02-13 | 196 |
| K252420 | Wearable Breast Pump (Model W12) | HGX | 2026-02-13 | 196 |
| K251754 | Wearable Breast Pump (Model S33) | HGX | 2025-09-08 | 91 |
| K250383 | Wearable Breast Pump (Model W6) | HGX | 2025-08-20 | 190 |
14 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Shenzhen TPH Technology Co., Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (159 510(k)s)
- Shenzhen Dongdixin Technology Co., Ltd. (26 510(k)s)
- Shenzhen Kaiyan Medical Equipment Co., Ltd. (24 510(k)s)
- Shenzhen Ulike Smart Electronics Co., Ltd. (23 510(k)s)
- Shenzhen AOJ Medical Technology Co., Ltd. (17 510(k)s)
- Shenzhen Beacon Display Technology Co., Ltd. (17 510(k)s)
- Shenzhen Med-Link Electronics Tech Co., Ltd. (14 510(k)s)
- Shenzhen Root Innovation Technology Co., Ltd. (13 510(k)s)
- Shenzhen Osto Technology Company Limited (12 510(k)s)
- Shenzhen RF Tech Co., Ltd. (12 510(k)s)
- Shenzhen Creative Industry Co., Ltd. (11 510(k)s)
- Shenzhen Jumper Medical Equipment Co., Ltd. (10 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Shenzhen TPH Technology Co., Ltd.?
FDA lists 24 510(k) clearances under the applicant name “Shenzhen TPH Technology Co., Ltd.” (first 2022, latest 2026), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Shenzhen TPH Technology Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Shenzhen TPH Technology Co., Ltd. is 138 days. Since 2017: 138 days, versus 151 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Shenzhen TPH Technology Co., Ltd.?
The most frequent FDA product codes under this applicant name are HGX (Pump, Breast, Powered, 24).
Next steps
- See all 24 Shenzhen TPH Technology Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code HGX, Shenzhen TPH Technology Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.