# DBY: Fab, Rhodamine, Antigen, Antiserum, Control

- Device class: 1; regulation: 21 CFR 866.5520; FDA's rule: 510(k) exempt
- FDA decisions: 6
- 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)
- 1977: 1
- 2001: 2
- 2002: 3

## Most-cited predicates
- K013304: BD Introsyte Precision Introducer, BD Introsyte Autogaurd Shielded Introducer (2002), cited by 4
- K022067: Convoy Advanced Delivery Sheath (2002), cited by 2
- K013919: Torflex Transseptal Guiding Sheath (2002), cited by 1
- K013282: Gore Introducer Sheath (2001), cited by 1
- K013866: Convoy Advanced Delivery Sheath Kit (2001), cited by 1

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