FDA applicant
Astute Medical, Inc.
FDA records 3 decisions for Astute Medical, Inc. (San Diego, CA) from 2014 to 2017: 2 510(k) clearances and 1 De Novo grant. All are in product code PIG (Acute Kidney Injury Test System). Its devices cite 1 predicate, 1 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Astute Medical, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2017
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2014.
Planning a device like Astute Medical, 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