Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Embla Systems — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
188 daysmedian FDA review time
633 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K180001 | Disposable BreathSensor Adult, Disposable BreathSensor Small | Embla Systems | 2019-09-27 | 633 | 0 |
| K173793 | XactTrace Single Use Respiratory Effort Belt System | Embla Systems | 2019-03-01 | 442 | 0 |
| K172703 | Disposable Snap Electrode | Embla Systems | 2017-11-13 | 67 | 0 |
| K163617 | REMbrandt | Embla Systems | 2017-04-11 | 110 | 0 |
| K162140 | RemLogic | Embla Systems | 2016-12-01 | 122 | 0 |
| K153353 | SANDMAN ELITE | Embla Systems | 2016-06-23 | 216 | 0 |
| K122516 | EMBLETTA MPR | Embla Systems | 2013-02-21 | 188 | 0 |
| K111742 | MDRIVE | Embla Systems | 2011-08-31 | 71 | 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