Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Researched, Novel Medical Devices (Rn/Md) · 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) |
|---|---|---|---|---|---|
| K944680 | SPLIT TOP WING NEEDLE CAP WITH OPTIONAL TUBING ANCHORS (AND | Researched, Novel Medical Devices (Rn/Md) | 1995-01-31 | 131 | 0 |
| K942753 | ONE STEP SPECIMEN COLLECTOR/TRANSPORT CONTAINER | Researched, Novel Medical Devices (Rn/Md) | 1994-11-02 | 145 | 0 |
| K925234 | BEDSIDE CADDY | Researched, Novel Medical Devices (Rn/Md) | 1993-11-19 | 399 | 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