Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Foracare, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
182 daysmedian FDA review time
269 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K173505 | FORA GTel Blood Glucose Monitoring System | Foracare, Inc. | 2018-08-09 | 269 | 0 |
| K133588 | FORA CARE BLOOD PRESSURE MONITORING SYSTEM | Foracare, Inc. | 2014-04-25 | 155 | 0 |
| K121706 | FORA V10 BLOOD GLUCOSE MONITORING SYSTEM | Foracare, Inc. | 2013-01-14 | 220 | 0 |
| K121118 | FORA COMFORTSCAN EAR THERMOMETER | Foracare, Inc. | 2012-06-15 | 64 | 0 |
| K110044 | FORA P30 PLUS MULTI-MODE BLOOD PRESSURE MONITORING SYSTEM | Foracare, Inc. | 2011-07-07 | 182 | 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