Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
NIKKISO CO., LTD. — Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
267 daysmedian FDA review time
484 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|
| K242155 | DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO) | NIKKISO CO., LTD. | 2025-05-15 | 296 | 0 |
| K242176 | BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLO | NIKKISO CO., LTD. | 2025-05-15 | 295 | 0 |
| K242479 | BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLO | NIKKISO CO., LTD. | 2025-05-15 | 267 | 0 |
| K231589 | Blood Tubing Lines for Hemodialysis AV06C-E | NIKKISO CO., LTD. | 2023-07-28 | 57 | 0 |
| K230514 | Blood Tubing Lines for Hemodialysis AL Series (Archloop), Bl | NIKKISO CO., LTD. | 2023-06-16 | 112 | 0 |
| K152938 | DBB-06 Hemodialysis Delivery System | NIKKISO CO., LTD. | 2016-03-18 | 165 | 0 |
| K091978 | DBB-06 HEMODIALYSIS DELIVERY SYSTEM | NIKKISO CO., LTD. | 2010-03-25 | 267 | 0 |
| K082719 | NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS, MODE | NIKKISO CO., LTD. | 2009-03-30 | 194 | 0 |
| K061519 | MODIFICATION TO DBB-05 HEMODIALYSIS DELIVERY SYSTEM | NIKKISO CO., LTD. | 2007-09-28 | 484 | 0 |
| K953996 | NIKKISO CO, LTD., FLX10GW, 12GW, 15GW, 18GW & 21GW HEMODIALY | NIKKISO CO., LTD. | 1997-03-19 | 573 | 0 |
| K803068 | NIKKISO ND-14 PARALLEL FLOW DIALYZER | NIKKISO CO., LTD. | 1981-03-04 | 90 | 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