# PBY: Temporary Tissue Marker

- Device class: 2; regulation: 21 CFR 878.4300; FDA's rule: 510(k) required
- FDA decisions: 7
- 510(k) review time 2021–2025: median 336 days (middle half 192–339)
- 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)
- 2013: 1
- 2016: 1
- 2017: 2
- 2021: 1
- 2022: 1
- 2023: 1

## Most-cited predicates
- K163541: Magseed Magnetic Marker System (2017), cited by 4
- K153044: Sentimag System, Sentimark Magnetic Marker Systerm (2016), cited by 3
- K120804: Cianna Medical Tissue Marker and Delivery System (2013), cited by 2
- K222643: Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit (2022), cited by 1
- K200734: Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit (2021), cited by 1

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