Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Shenzhen Caremed Medical Technology Co., Ltd. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
343 daysmedian FDA review time
428 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K191279 | Disposable SpO2 Sensor | Shenzhen Caremed Medical Technology Co., Ltd. | 2019-12-06 | 207 | 0 |
| K182751 | Reusable Temperature Probe | Shenzhen Caremed Medical Technology Co., Ltd. | 2019-09-06 | 343 | 0 |
| K182755 | Disposable Temperature Probe | Shenzhen Caremed Medical Technology Co., Ltd. | 2018-12-21 | 84 | 0 |
| K182433 | Reusable Blood Pressure Cuff, Disposable Blood Pressure Cuff | Shenzhen Caremed Medical Technology Co., Ltd. | 2018-12-17 | 102 | 0 |
| K153184 | Caremed Reusable & Disposable SPO2 Sensors | Shenzhen Caremed Medical Technology Co., Ltd. | 2017-01-04 | 428 | 0 |
| K153188 | Caremed patient cable and leadwires | Shenzhen Caremed Medical Technology Co., Ltd. | 2016-10-24 | 356 | 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