Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Kawasumi Laboratories Co., Ltd. · Predicate Candidate Screening
18 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
278 daysmedian FDA review time
462 days90th percentile
18clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K994323 | KAWASUMI LABORATORIES PHILEBOTOMY SET | Kawasumi Laboratories Co., Ltd. | 2000-03-08 | 77 | 0 |
| K974829 | NON-PVC FLUID PATH PORT ACCESS INFUSION SET (WITH AND WITHOU | Kawasumi Laboratories Co., Ltd. | 1998-02-12 | 50 | 0 |
| K964117 | NON-PVC FLUID PATH PORT ACCESS INFUSION SET WITH SLIT SEPTUM | Kawasumi Laboratories Co., Ltd. | 1997-03-14 | 150 | 0 |
| K935514 | VACUUM TUBE HOLDER CULTURE MEDIUM VIAL HOLDER | Kawasumi Laboratories Co., Ltd. | 1994-02-10 | 86 | 0 |
| K935506 | MULTI-SAMPLE LUER ADAPTER FOR BLOOD SAMPLE COLLECTION | Kawasumi Laboratories Co., Ltd. | 1994-02-03 | 79 | 0 |
| K935505 | WINGED COLLECTION SET W/MULTI-SAMPLE LUER ADAPTER | Kawasumi Laboratories Co., Ltd. | 1994-02-03 | 79 | 0 |
| K930012 | KAWASUMI LABORATORIES K-CUFF | Kawasumi Laboratories Co., Ltd. | 1993-12-14 | 344 | 0 |
| K921901 | PORT ACCESS INFUSION SET | Kawasumi Laboratories Co., Ltd. | 1993-09-10 | 506 | 0 |
| K921902 | PORT ACCESS NEEDLE | Kawasumi Laboratories Co., Ltd. | 1993-07-28 | 462 | 0 |
| K923323 | INTERMITTENT INJECTION SITE | Kawasumi Laboratories Co., Ltd. | 1993-07-13 | 371 | 0 |
| K896894 | KAWASUMI BLOOD ADMINISTRATION SET | Kawasumi Laboratories Co., Ltd. | 1990-09-12 | 278 | 0 |
| K896895 | KAWASUMI I.V. ADMINISTRATION SET | Kawasumi Laboratories Co., Ltd. | 1990-09-12 | 278 | 0 |
| K896896 | KAWASUMI SMALL VEIN INFUSION SET | Kawasumi Laboratories Co., Ltd. | 1990-09-12 | 278 | 0 |
| K896892 | KAWASUMI Y-TYPE BLOOD ADMINISTRATION SET | Kawasumi Laboratories Co., Ltd. | 1990-09-12 | 278 | 0 |
| K896893 | KAWASUMI I.V. ADMINISTRATION SET WITH BURETTE | Kawasumi Laboratories Co., Ltd. | 1990-09-12 | 278 | 0 |
| K883748 | RENAK-E & RENEK-A SERIES HOLLOW FIBER DIALYZERS | Kawasumi Laboratories Co., Ltd. | 1989-01-31 | 152 | 0 |
| K873421 | KAWASUMI A.V. FISTULA SET | Kawasumi Laboratories Co., Ltd. | 1987-10-09 | 45 | 0 |
| K873516 | KAWASUMI BLOOD TUBING LINE | Kawasumi Laboratories Co., Ltd. | 1987-10-05 | 35 | 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