Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
QNS · Predicate Candidate Screening
3 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K242956 | LDS Needle; OcuSafe® LDS Needle; SteriCap® LDS Safety Needle | Ocuject, LLC | 2024-10-25 | 30 | 0 |
| K231734 | STERiJECT Low Dead Space, STERiJECT The Invisible Needle | Tsk Laboratory International Japan KK | 2024-03-08 | 268 | 0 |
| K210444 | EZ-Injec LDV Sterile Safety Needle | Poonglim Pharmatech, Inc. | 2021-02-16 | 0 | 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