Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Telemed — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
217 daysmedian FDA review time
291 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K211248 | ArtUs | Telemed | 2022-02-11 | 291 | 0 |
| K163121 | SmartUs EXT-1M/3M | Telemed | 2017-08-10 | 275 | 0 |
| K161968 | MicrUs | Telemed | 2016-11-03 | 108 | 0 |
| K113184 | LOGICSCAN 64 LOGICSCAN 128 | Telemed | 2012-01-26 | 90 | 0 |
| K102253 | ECHO BLASTER | Telemed | 2011-03-14 | 217 | 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