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Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Deka Research and Development — Predicate Candidate Screening

13 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

106 daysmedian FDA review time
249 days90th percentile
13clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K261672twiist Automated Insulin Delivery (AID) SystemDeka Research and Development2026-06-17270
K261530iiSure Infusion SetDeka Research and Development2026-06-03260
K243841Sparta Infusion Set for InsulinDeka Research and Development2025-08-012310
K240920HemoCare Bicarbonate Concentrate Set (BCS)Deka Research and Development2024-07-12990
K233557HemoCare Hemodialysis SystemDeka Research and Development2024-07-122490
K240256Remunity SystemDeka Research and Development2024-06-121330
K241178DEKA ACE Pump SystemDeka Research and Development2024-05-24250
K233952DEKA ACE Pump SystemDeka Research and Development2024-03-13890
K234055DEKA LoopDeka Research and Development2024-03-13820
K232316DEKA Infusion System, DEKA Administration SetDeka Research and Development2024-03-012110
K213536DEKA ACE Pump SystemDeka Research and Development2023-07-256270
K202690Remunity Pump for Remodulin (treprostinil) InjectionDeka Research and Development2020-12-301060
K151525Amia Automated PD System with SharesourceDeka Research and Development2015-10-091231

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