Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Globalcare Medical Technology Co., Ltd. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
125 daysmedian FDA review time
221 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253896 | TENS/EMS device (GUSE01) | Globalcare Medical Technology Co., Ltd. | 2026-03-04 | 89 | 0 |
| K250136 | Globalcare Blood Pressure Monitor (GUS610) | Globalcare Medical Technology Co., Ltd. | 2025-04-08 | 81 | 0 |
| K222160 | GUS610 Blood pressure monitor | Globalcare Medical Technology Co., Ltd. | 2022-11-22 | 125 | 0 |
| K192633 | GUS831 Compressor Nebulizer | Globalcare Medical Technology Co., Ltd. | 2020-05-01 | 221 | 0 |
| K192609 | Globalcare Blood Pressure Monitor | Globalcare Medical Technology Co., Ltd. | 2020-04-21 | 214 | 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