Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Ceragem Medisys, 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) |
|---|---|---|---|---|---|
| K141829 | GLUCOVITAAL H1A BLOOD GLUCOSE MONITORING SYSTEM | Ceragem Medisys, Inc. | 2014-09-24 | 79 | 0 |
| K140141 | LABONACHECK GLUPPY BLOOD GLUCOSE MONITORING SYSTEM | Ceragem Medisys, Inc. | 2014-07-03 | 162 | 0 |
| K131727 | CERA-CHEK 1070 BLOOD GLUCOSE MONITORING SYSTEM | Ceragem Medisys, Inc. | 2014-02-28 | 261 | 0 |
| K102751 | LABONACHECK GLUPPY BLOOD GLUCOSE MONITORING SYSTEM | Ceragem Medisys, Inc. | 2013-02-11 | 872 | 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