Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sb-Kawasumi Laboratories, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
120 daysmedian FDA review time
272 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252355 | K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressu | Sb-Kawasumi Laboratories, Inc. | 2025-11-26 | 120 | 0 |
| K241855 | SB Knife Jr2 (MD-47702 and MD-47702L) | Sb-Kawasumi Laboratories, Inc. | 2025-03-26 | 272 | 0 |
| K230408 | K-SHIELD Zen (Model Numbers: PBMH/ PBMA/ PBM) | Sb-Kawasumi Laboratories, Inc. | 2023-06-01 | 106 | 0 |
| K223810 | Kawasumi Multiple Sample Adapter with Pre-Attached Holder (M | Sb-Kawasumi Laboratories, Inc. | 2023-02-24 | 66 | 0 |
| K220799 | K-SHIELD Zen | Sb-Kawasumi Laboratories, Inc. | 2022-08-29 | 164 | 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