Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KSB · Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
78 daysmedian FDA review time
367 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K172957 | Kawasumi Laboratories Blood Drawing Kit (BDK) System | Kawasumi Laboratories, Inc. | 2018-09-28 | 367 | 0 |
| K001043 | KAWASUMI LABORATORY BLOOD DRAWING KIT | Kawasumi Laboratories America, Inc. | 2000-05-19 | 49 | 0 |
| K820447 | ALPHA PLASMA TRANSFER SET | Alpha Therapeutic Corp. | 1982-04-14 | 55 | 0 |
| K802940 | SUPER-SPIKE TRANSFER SET | Geneva Laboratories, Inc. | 1981-01-15 | 57 | 0 |
| K791130 | FLU-VEN TK-2 | Venospital, Inc. | 1979-09-04 | 78 | 0 |
| K791131 | FLU VEN TR-1 | Venospital, Inc. | 1979-09-04 | 78 | 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