Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
QJY · 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) |
|---|---|---|---|---|---|
| K243354 | Remunity System | Deka Research & Development Corp. | 2024-11-27 | 29 | 0 |
| K240256 | Remunity System | Deka Research and Development | 2024-06-12 | 133 | 0 |
| K202690 | Remunity Pump for Remodulin (treprostinil) Injection | Deka Research and Development | 2020-12-30 | 106 | 0 |
| K191313 | Unity Subcutaneous Infusion System for Remodulin | DEKA Research & Development | 2020-02-21 | 282 | 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