FDA applicant
Koru Medical Systems, Inc.
FDA records 2 decisions for Koru Medical Systems, Inc. (Mahwah, NJ) from 2023 to 2026: 2 510(k) clearances. All are in product code FRN (Pump, Infusion). Its devices cite 2 predicates, 0 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Koru Medical Systems”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Koru Medical Systems, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2023
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2023.
Planning a device like Koru Medical 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