Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
IYP — 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) |
|---|---|---|---|---|---|
| K921878 | SCANMATE III | Circadian, Inc. | 1992-09-11 | 144 | 0 |
| K844189 | LINEAR SCANNER PROBE ELSCINT LTD. TL-35 | Elscint, Inc. | 1985-02-25 | 118 | 0 |
| K812893 | SUPERFLAB | Mick Radio-Nuclear Instruments, Inc. | 1981-12-08 | 54 | 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