Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ino Therapeutics — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
140 daysmedian FDA review time
173 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K130605 | INOMAX DSIR (DELIVERY SYSTEM) | Ino Therapeutics | 2013-05-02 | 56 | 0 |
| K122689 | INOBLENDER | Ino Therapeutics | 2012-11-07 | 64 | 0 |
| K121021 | INOMAX DS (DELIVERY SYSTEM) | Ino Therapeutics | 2012-09-24 | 173 | 0 |
| K110344 | INOMAX DSIR (DELIVERY SYSTEM) | Ino Therapeutics | 2011-06-24 | 140 | 0 |
| K093922 | INOMAX DS | Ino Therapeutics | 2010-04-15 | 114 | 1 |
| K080484 | INOMAX DS (DELIVERY SYSTEM), MODEL 10003 | Ino Therapeutics | 2008-08-06 | 166 | 0 |
| K061901 | INO THERAPEUTICS INOMAX DS (DELIVERY SYSTEM), MODEL 10003 | Ino Therapeutics | 2006-12-14 | 162 | 3 |
| K052663 | INO THERAPEUTICS INOBLENDER, MODEL 10004 | Ino Therapeutics | 2005-11-04 | 38 | 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