Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Inovel, LLC · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
24 daysmedian FDA review time
47 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K063747 | INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL | Inovel, LLC | 2007-01-12 | 24 | 0 |
| K062665 | INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL | Inovel, LLC | 2006-10-24 | 47 | 0 |
| K061859 | INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS & SURGICAL MA | Inovel, LLC | 2006-07-12 | 12 | 0 |
| K051182 | INOVEL HEALTH CARE MODEL N95 PARTICULATE RESPIRATORS AND SUR | Inovel, LLC | 2005-05-19 | 10 | 1 |
| K042267 | INOVEL HEALTH CARE N95 PARTICULATE RESPIRATOR AND SURGICAL M | Inovel, LLC | 2004-09-30 | 38 | 1 |
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