Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
DEKA Research & Development — 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) |
|---|---|---|---|---|---|
| K191313 | Unity Subcutaneous Infusion System for Remodulin | DEKA Research & Development | 2020-02-21 | 282 | 0 |
| K190182 | Unity Subcutaneous Delivery System for Remodulin | DEKA Research & Development | 2019-05-06 | 94 | 0 |
| K153760 | Volumetric Infusion Controller | DEKA Research & Development | 2016-10-03 | 278 | 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