Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Kawasumi Laboratories America, Inc. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
77 daysmedian FDA review time
77 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K102890 | K-SHIELD SMALL VEIN INFUSION / WINGED COLLECTION SET W/ ANTI | Kawasumi Laboratories America, Inc. | 2010-10-21 | 21 | 0 |
| K030385 | IV ADD-ON FILTER ADMINISTRATION SET WITH AND WITHOUT Y CONNE | Kawasumi Laboratories America, Inc. | 2003-04-15 | 69 | 0 |
| K001423 | KAWASUMI LABORATORIES IV ADMINISTRATION SET, PRIMARY | Kawasumi Laboratories America, Inc. | 2000-07-21 | 77 | 0 |
| K001424 | KAWASUMI LABORATORIES IV ADMINISTRATION SET, STANDARD | Kawasumi Laboratories America, Inc. | 2000-07-21 | 77 | 0 |
| K001426 | KAWASUMI LABORATORIES IV ADMINISTRATION SET WITH FILTER | Kawasumi Laboratories America, Inc. | 2000-07-21 | 77 | 0 |
| K001043 | KAWASUMI LABORATORY BLOOD DRAWING KIT | Kawasumi Laboratories America, Inc. | 2000-05-19 | 49 | 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