Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Teleemg, LLC — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
192 daysmedian FDA review time
326 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250689 | CloudTMS Edge | Teleemg, LLC | 2025-09-14 | 192 | 0 |
| K233742 | CloudTMS Edge for OCD | Teleemg, LLC | 2023-12-22 | 30 | 0 |
| K221129 | CloudTMS for OCD | Teleemg, LLC | 2023-03-10 | 326 | 0 |
| K173441 | Neurosoft TMS (also CloudTMS) | Teleemg, LLC | 2017-12-13 | 37 | 0 |
| K160309 | Neurosoft TMS | Teleemg, LLC | 2016-12-22 | 322 | 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