Shenzhen Pump Medical System Co., Ltd.: FDA clearances and approvals
Shenzhen Pump Medical System Co., Ltd. has 7 FDA 510(k) clearances (first 2013, latest 2017), across 3 product codes in 2 review panels. Median 510(k) review time: 282 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2013 | 1 | 319 |
| 2014 | 2 | 228 |
| 2015 | 1 | 168 |
| 2016 | 2 | 218 |
| 2017 | 1 | 288 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Shenzhen Pump Medical System Co., Ltd.'s cleared 510(k)s took a median 288 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 176 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 5 | 5 |
| DXQ | Blood Pressure Cuff | 1 | 1 |
| FLL | Continuous Measurement Thermometer | 1 | 1 |
Review panels
- Cardiovascular (6)
- General Hospital (1)
Most recent Shenzhen Pump Medical System Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K161712 | Arm automatic blood pressure monitor | DXN | 2017-04-05 | 288 |
| K161708 | Arm automatic blood pressure monitor | DXN | 2016-11-22 | 154 |
| K151258 | Arm automatic blood pressure monitor | DXN | 2016-02-18 | 282 |
| K151810 | Bpump Blood Pressure Cuff | DXQ | 2015-12-17 | 168 |
| K141416 | BLOOD PRESSURE MONITOR | DXN | 2014-10-09 | 133 |
| K131210 | ELECTRONIC THERMOMETER | FLL | 2014-03-18 | 323 |
| K130325 | ARM AUTOMATIC BLOOD PRESSURE MONITOR | DXN | 2013-12-24 | 319 |
Recalls
openFDA lists no recalls under a recalling firm named Shenzhen Pump Medical System Co., Ltd..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Shenzhen Pump Medical System Co., Ltd. have?
Shenzhen Pump Medical System Co., Ltd. has 7 FDA 510(k) clearances (first 2013, latest 2017), across 3 product codes in 2 review panels.
How long does FDA take to clear Shenzhen Pump Medical System Co., Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Shenzhen Pump Medical System Co., Ltd.'s cleared 510(k)s is 282 days.
What devices does Shenzhen Pump Medical System Co., Ltd. make?
Its most frequent FDA product codes are DXN (System, Measurement, Blood-Pressure, Non-Invasive, 5); DXQ (Blood Pressure Cuff, 1); FLL (Continuous Measurement Thermometer, 1).
Has Shenzhen Pump Medical System Co., Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Shenzhen Pump Medical System Co., Ltd. Related entities may recall under other names.
Next steps
- See all 7 Shenzhen Pump Medical System Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code DXN, Shenzhen Pump Medical System Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.