Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Globalcare Intl., Inc. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K913444 | GLOBALCARE EMS | Globalcare Intl., Inc. | 1991-10-21 | 80 | 0 |
| K913373 | GLOBALCARE ELECTRODE | Globalcare Intl., Inc. | 1991-08-29 | 31 | 0 |
| K910244 | GLOBAL CARE MICRO II | Globalcare Intl., Inc. | 1991-07-09 | 168 | 0 |
| K903394 | GLOBALCARE MICRO 11 AND MICROCARE (TENS) | Globalcare Intl., Inc. | 1991-05-06 | 283 | 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