Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Kurin, Inc. · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K220677 | Kurin Blood Culture Collection Set with Kurin Lock Technolog | Kurin, Inc. | 2023-04-28 | 416 | 0 |
| K191832 | Kurin Blood Culture Collection Set with Kurin Lock Technolog | Kurin, Inc. | 2020-02-04 | 210 | 0 |
| K181895 | Kurin PIV Blood Collection Set with High Pressure | Kurin, Inc. | 2019-01-18 | 186 | 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