Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
eVent Medical, Ltd. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
231 daysmedian FDA review time
347 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K130178 | INSPIRATION VENTILATOR SYSTEM 5I/7I | eVent Medical, Ltd. | 2013-10-29 | 277 | 1 |
| K051550 | INSPIRATION VENTILATOR SYSTEM | eVent Medical, Ltd. | 2005-07-12 | 29 | 1 |
| K040220 | MEDICAL AIR COMPRESSOR | eVent Medical, Ltd. | 2004-06-09 | 128 | 0 |
| K030341 | MODIFICATION TO INSPIRATION VENTILATOR SYSTEM | eVent Medical, Ltd. | 2004-01-16 | 347 | 0 |
| K021112 | INSPIRATION VENTILATOR SYSTEM | eVent Medical, Ltd. | 2002-11-22 | 231 | 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