Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Electromed, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
92 daysmedian FDA review time
288 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K222496 | Electromed SmartVest Airway Clearance System | Electromed, Inc. | 2022-11-18 | 92 | 0 |
| K132794 | SMARTVEST AIRWAY CLEARANCE SYSTEM | Electromed, Inc. | 2013-12-19 | 104 | 0 |
| K053248 | SMARTVEST AIRWAY CLEARANCE SYSTEM, MODEL TL | Electromed, Inc. | 2005-12-01 | 10 | 0 |
| K040367 | MEDPULSE RESPIRATORY VEST SYSTEM, MODEL 2000EZ | Electromed, Inc. | 2004-04-07 | 54 | 0 |
| K982889 | MEDPULSE RESPIRATORY VEST SYSTEM, MODEL 1000 | Electromed, Inc. | 1999-06-01 | 288 | 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