# PIR: Mercy Tape 2d And 3d Models

- Device class: 1; regulation: 21 CFR 878.4800; FDA's rule: 510(k) required
- FDA decisions: 2
- 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)
- 2015: 1
- 2019: 1

## Most-cited predicates
- K142469: 2D Mercy TAPE & 3D Mercy TAPE (2015), cited by 1

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