Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Nipro Diagnostics, 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) |
|---|---|---|---|---|---|
| K150052 | TRUE METRIX AIR Self-Monitoring Blood Glucose System, TRUE M | Nipro Diagnostics, Inc. | 2015-03-26 | 73 | 1 |
| K140100 | TRUE METRIX SELF-MONITORING BLOOD GLUCOSE SYSTEM, TRUE METRI | Nipro Diagnostics, Inc. | 2014-08-01 | 198 | 3 |
| K132072 | TRUE METRIX SELF-MONITORING BLOOD GLUCOSE SYSTEM, TRUE METRI | Nipro Diagnostics, Inc. | 2013-08-15 | 43 | 0 |
| K120989 | TRUE METRIX SELF-MONITORING BLOOD GLUCOSE SYSTEM, TRUE METRI | Nipro Diagnostics, Inc. | 2013-04-24 | 387 | 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