FDA applicant
Deka Research and Development
FDA records 16 decisions for Deka Research and Development (Manchester, NH) from 2015 to 2026: 16 510(k) clearances. Most are in product codes QFG (Alternate Controller Enabled Insulin Infusion…) and QJI (Interoperable Automated Glycemic Controller). Since 2016 its 510(k)s took a median of 89 days from receipt to decision, against 150 for FDA’s reviews in the same codes and years. Its devices cite 20 predicates, 5 of them its own earlier devices. 8 recalls are linked to its devices.
FDA’s records also spell it “Deka Research and Development Corp.”, “Deka Research and Development Corporation”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Deka Research and Development’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
1in 2023
Class I Class II/III not classified
Planning a device like Deka Research and Development’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Deka”
FDA records each applicant name separately; these may or may not be the same firm.