Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
MRO · Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K122689 | INOBLENDER | Ino Therapeutics | 2012-11-07 | 64 | 0 |
| K052663 | INO THERAPEUTICS INOBLENDER, MODEL 10004 | Ino Therapeutics | 2005-11-04 | 38 | 0 |
| K011874 | FADASIS MEDICAL FM-1 NO BLENDER | Fadasis Medical, Inc. | 2001-07-20 | 35 | 0 |
| K003665 | FADASSI MEDICAL FM-1 NO BLENDER | Fadasis Medical, Inc. | 2001-02-23 | 87 | 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