Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LWI · Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K960421 | SINUSCAN 102/SINUSPRINT | Ferguson Medical | 1997-04-16 | 443 | 0 |
| K960044 | ULTRAMAX/MODEL NUMBER A1 | Entlab OY | 1996-08-02 | 213 | 0 |
| K960241 | CPR GENERAL SURGERY TRAY | Custom Pack Reliability | 1996-03-22 | 66 | 0 |
| K874081 | ENTERSCAN | Pie Data Medical BV | 1987-12-31 | 85 | 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