# PIG: Acute Kidney Injury Test System

- Device class: 2; regulation: 21 CFR 862.1220; FDA's rule: 510(k) required
- FDA decisions: 5
- 510(k) review time 2021–2025: median 285 days (middle half 187–382)
- Recalls: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2014: 1
- 2016: 1
- 2017: 1
- 2022: 1
- 2023: 1

## Most-cited predicates
- 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

Source page: https://510kreport.com/product-code/PIG
Data by year (CSV): https://510kreport.com/product-code/PIG.csv