# PPU: Microbial Colony Image Assessment System

- Device class: 2; regulation: 21 CFR 866.2190; FDA's rule: 510(k) required
- FDA decisions: 3
- Recalls: 0 (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)
- 2016: 1
- 2019: 1
- 2026: 1

## Most-cited predicates
- K183648: APAS Independence with Urine Analysis Module (2019), cited by 2
- DEN150059: APAS Compact with Urine Analysis Module (2016), cited by 1

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