Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
Deka Research & Development Corp. — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
52 daysmedian FDA review time
609 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250930 | twiist system | Deka Research & Development Corp. | 2025-04-02 | 5 | 0 |
| K250357 | RemunityPRO™ Pump for Remodulin® (treprostinil) Injection | Deka Research & Development Corp. | 2025-03-11 | 32 | 0 |
| K243354 | Remunity System | Deka Research & Development Corp. | 2024-11-27 | 29 | 0 |
| K172601 | Next Generation iBOT | Deka Research & Development Corp. | 2018-03-02 | 184 | 0 |
| K124018 | AMIA AUTOMATED PD SYSTEM | Deka Research & Development Corp. | 2013-06-14 | 169 | 1 |
| K093915 | DEKA TAC DEVICE | Deka Research & Development Corp. | 2011-08-23 | 609 | 0 |
| K103220 | VOYAGER PERITONEAL DIALYSIS SYSTEM | Deka Research & Development Corp. | 2011-07-29 | 270 | 0 |
| K863204 | DEKA JR. | Deka Research & Development Corp. | 1986-09-03 | 15 | 0 |
| K843254 | DK*300 VOLUMETRIC INFUSION CONTROLLER | Deka Research & Development Corp. | 1984-10-11 | 52 | 0 |
| K843054 | DEKA SOLUTION ADMIN. SET DK 302-A | Deka Research & Development Corp. | 1984-09-13 | 41 | 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