Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Yukon Medical, LLC · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
22 daysmedian FDA review time
366 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K240761 | Arisure® Closed Male Luer with Spike Adapter (YM060) | Yukon Medical, LLC | 2025-03-21 | 366 | 0 |
| K243486 | SmartSiteTM Vented Vial Access Device | Yukon Medical, LLC | 2024-12-06 | 28 | 0 |
| K201422 | Arisure Closed System Drug Transfer Device (CSTD) | Yukon Medical, LLC | 2021-03-02 | 277 | 0 |
| K151963 | SmartSite Vented Vial Access Device | Yukon Medical, LLC | 2015-07-31 | 15 | 0 |
| K132863 | SMARTSITE VIALSHIELD | Yukon Medical, LLC | 2013-10-04 | 22 | 0 |
| K122265 | VIALOK SINGLE VIAL ACCESS DEVICE VENTED | Yukon Medical, LLC | 2012-08-14 | 15 | 0 |
| K121182 | VIALOK NON-VENTED | Yukon Medical, LLC | 2012-05-03 | 15 | 0 |
| K120799 | ARISURE NEUTRAL VALVE | Yukon Medical, LLC | 2012-03-30 | 14 | 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