Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Nipro Diabetes Systems, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
184 daysmedian FDA review time
263 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K071613 | AMIGO INSULIN PUMP | Nipro Diabetes Systems, Inc. | 2007-12-14 | 184 | 0 |
| K050312 | AMIGO INSULIN PUMP | Nipro Diabetes Systems, Inc. | 2005-05-09 | 90 | 0 |
| K014114 | GLUCOPRO SYRINGE, MODEL GPSY-XXXXXXXX | Nipro Diabetes Systems, Inc. | 2002-06-26 | 194 | 0 |
| K013309 | GLUCOPRO EVO INFUSION PUMP | Nipro Diabetes Systems, Inc. | 2002-06-24 | 263 | 1 |
| K011120 | GLUCOPRO INFUSION SET, MODEL GPISXXXXXXXX SERIES | Nipro Diabetes Systems, Inc. | 2001-05-08 | 26 | 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