Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ino Therapeutics, LLC — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
73 daysmedian FDA review time
203 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K092545 | INOMAX DS (DELIVERY SYSTEM), MODEL 10003 | Ino Therapeutics, LLC | 2010-03-10 | 203 | 0 |
| K090958 | INOMAX DS (DELIVERY SYSTEM) | Ino Therapeutics, LLC | 2009-06-18 | 73 | 0 |
| K081691 | INOMAX DS (DELIVERY SYSTEM) | Ino Therapeutics, LLC | 2008-08-28 | 72 | 0 |
| K071516 | INOMAX DS | Ino Therapeutics, LLC | 2007-10-03 | 121 | 0 |
| K070867 | INOMAX DS (DELIVERY SYSTEM), MODEL 10003 | Ino Therapeutics, LLC | 2007-04-27 | 29 | 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