Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Infrascan, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
259 daysmedian FDA review time
614 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K241389 | Infrascanner Model 2500 (Model 2500) | Infrascan, Inc. | 2024-12-12 | 211 | 0 |
| K211617 | Infrascanner | Infrascan, Inc. | 2022-02-09 | 259 | 0 |
| K200203 | Infrascanner | Infrascan, Inc. | 2020-07-10 | 164 | 0 |
| K120949 | INFRASCANNER | Infrascan, Inc. | 2013-01-11 | 287 | 0 |
| DEN100002 | INFRASCANNER, MODEL 1000 | Infrascan, Inc. | 2011-12-13 | 614 | 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