# Astute Medical, Inc.

- Location (FDA's records): San Diego, CA
- FDA decisions: 3 (2014–2017): 2 510(k) clearances and 1 De Novo grant
- Product codes: PIG (3)
- Predicates its devices cite: 1 (1 its own); citations of its devices by later devices: 3 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- bioMerieux, Inc.: 1 (https://510kreport.com/company/biomerieux)
- Bioporto Diagnostic, Inc.: 1 (https://510kreport.com/company/bioporto-diagnostic)

## Its most-cited devices
- K171482: NEPHROCHECK Test System (2017), cited by 1
- DEN130031: Nephrocheck Test System (2014), cited by 1
- K153165: NEPHROCHECK Test Kit, ASTUTE140 Meter, NEPHROCHECK Liquid Controls Kit, NEPHROCHECK Calibration Verification (Cal Vers) Kit (2016), cited by 1

## Recent decisions
- K171482: NEPHROCHECK Test System (Nov 16, 2017)
- K153165: NEPHROCHECK Test Kit, ASTUTE140 Meter, NEPHROCHECK Liquid Controls Kit, NEPHROCHECK Calibration Verification (Cal Vers) Kit (Jun 1, 2016)
- DEN130031: Nephrocheck Test System (Sep 5, 2014)

Source page: https://510kreport.com/company/astute-medical