Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
ESI · Predicate Candidate Screening
2 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K954401 | GASTROTEC | Patrick C. Jacobssen | 1996-04-25 | 218 | 0 |
| K911212 | LM-150HT LIGHT SOURCE | Leisegang Medical, Inc. | 1991-05-23 | 65 | 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