Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Cilag GmbH International · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K131363 | ONETOUCH VERIO BLOOD GLUCOSE MONITORING SYSTEM | Cilag GmbH International | 2013-08-30 | 109 | 0 |
| K120708 | ONETOUCH VERIO SYNC BLOOD GLUCOSE MONITORING SYSTEM | Cilag GmbH International | 2013-02-07 | 336 | 0 |
| K110637 | ONETOUCH VERIO (TM) IQ BLOOD GLUCOSE MONITORING SYSTEM | Cilag GmbH International | 2011-09-07 | 187 | 1 |
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