Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Emsi — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
225 daysmedian FDA review time
248 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K140467 | FLEX-MT + | Emsi | 2014-10-07 | 225 | 0 |
| K102202 | GS 3000 | Emsi | 2010-11-23 | 111 | 0 |
| K090889 | EMSI GARMENT ELECTRODES | Emsi | 2009-12-04 | 248 | 0 |
| K090717 | FLEX-TENS | Emsi | 2009-05-08 | 51 | 0 |
| K083030 | TENS-EMS-14 | Emsi | 2009-02-05 | 118 | 0 |
| K071869 | TENS/IF 14 | Emsi | 2008-03-07 | 245 | 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