Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Nissho Corp. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
91 daysmedian FDA review time
511 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K954676 | NIPRO ARTERIAL & VENOUS BLOOD TUBING SET FOR HEMODIALYSIS | Nissho Corp. | 1997-03-04 | 511 | 0 |
| K955182 | NIPRO ARTERIAL VENOUS FISTULA NEEDLE | Nissho Corp. | 1996-06-04 | 204 | 0 |
| K960051 | NIPRO SAFELET CATH | Nissho Corp. | 1996-03-28 | 84 | 0 |
| K955053 | NIPRO SCALP VEIN SET (DISPOSABL PSV SET) | Nissho Corp. | 1996-01-04 | 59 | 0 |
| K944355 | NIPRO BRANDED DISPOSABLE SYRINGES, NEEDLES | Nissho Corp. | 1994-12-07 | 91 | 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