Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Shenzhen Pump Medical System Co., Ltd. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
282 daysmedian FDA review time
323 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K161712 | Arm automatic blood pressure monitor | Shenzhen Pump Medical System Co., Ltd. | 2017-04-05 | 288 | 0 |
| K161708 | Arm automatic blood pressure monitor | Shenzhen Pump Medical System Co., Ltd. | 2016-11-22 | 154 | 0 |
| K151258 | Arm automatic blood pressure monitor | Shenzhen Pump Medical System Co., Ltd. | 2016-02-18 | 282 | 0 |
| K151810 | Bpump Blood Pressure Cuff | Shenzhen Pump Medical System Co., Ltd. | 2015-12-17 | 168 | 0 |
| K141416 | BLOOD PRESSURE MONITOR | Shenzhen Pump Medical System Co., Ltd. | 2014-10-09 | 133 | 0 |
| K131210 | ELECTRONIC THERMOMETER | Shenzhen Pump Medical System Co., Ltd. | 2014-03-18 | 323 | 0 |
| K130325 | ARM AUTOMATIC BLOOD PRESSURE MONITOR | Shenzhen Pump Medical System Co., Ltd. | 2013-12-24 | 319 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda