FDA applicant
R&D Systems, Inc.
FDA records 79 decisions for R&D Systems, Inc. (Minneapolis, MN) from 1978 to 2016: 79 510(k) clearances. Most are in product codes JPK (Mixture, Hematology Quality Control) and KRX (Calibrator For Cell Indices). Its devices cite 28 predicates, 18 of them its own earlier devices. 8 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided R&D Systems, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2016
2026 so far, outlined.
Recalls per year
2in 2022
Class I Class II/III not classified
Planning a device like R&D Systems, Inc.’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) Report