# K171482: NEPHROCHECK Test System

- Pathway: 510(k) (Traditional)
- Applicant: Astute Medical, Inc.
- Decided: Nov 16, 2017 after 181 days
- Product code: PIG (Acute Kidney Injury Test System)
- Device class: 2
- Regulation: 21 CFR 862.1220
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K153165 (2016). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153165: NEPHROCHECK Test Kit, ASTUTE140 Meter, NEPHROCHECK Liquid Controls Kit, NEPHROCHECK Calibration Verification (Cal Vers) Kit, Astute Medical, Inc. (2016) Summary page 5.

## Most influential descendants
- K210793: Vidas Nephrocheck (2022), 0 descendants of its own

## Indications for use
The Astute Medical NEPHROCHECK® Test System is intended to be used in conjunction with clinical evaluation in patients who currently have or have had within the past 24 hours acute cardiovascular and or respiratory compromise and are ICU patients as an aid in the risk assessment for moderate or severe acute kidney injury (AKI) within 12 hours of patient assessment. The NEPHROCHECK® Test System is intended to be used in patients 21 years of age or older.

Source page: https://510kreport.com/device/K171482
Methodology: https://510kreport.com/methodology