FDA applicant
Acist Medical Systems, Inc.
FDA records 24 decisions for Acist Medical Systems, Inc. (Eden Prairie, MN) from 1999 to 2026: 24 510(k) clearances. Most are in product codes DXT (Injector And Syringe, Angiographic) and OBJ (Catheter, Ultrasound, Intravascular). Since 2016 its 510(k)s took a median of 123 days from receipt to decision, against 135 for FDA’s reviews in the same codes and years. Its devices cite 21 predicates, 11 of them its own earlier devices. 8 recalls are linked to its devices, 1 Class I.
FDA’s records also spell it “Acist Medical Systems”, “ACIST Medical Systems, Inc.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Acist Medical Systems, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
1in 2021
Class I Class II/III not classified
Planning a device like Acist 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.
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