Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Intuit Medical Products, LLC · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K181546 | Dillard Nasal Balloon Catheter | Intuit Medical Products, LLC | 2020-01-03 | 570 | 0 |
| K153484 | Dillard Airway Dilatation System | Intuit Medical Products, LLC | 2016-07-27 | 237 | 0 |
| K143738 | DSS Sinusplasty Balloon Catheter | Intuit Medical Products, LLC | 2015-08-27 | 240 | 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