# BSY: Catheters, Suction, Tracheobronchial

- Device class: 1; regulation: 21 CFR 868.6810; FDA's rule: 510(k) exempt
- FDA decisions: 116
- Recalls: 30 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1991: 6
- 1992: 2
- 1993: 4
- 1994: 5
- 1995: 6
- 1996: 3
- 1997: 4
- 1998: 2
- 1999: 1
- 2003: 1

## Most-cited predicates
- K902383: Steri-Cath (TM) (1990), cited by 2
- K972258: HI-Care Closed Suction System (1997), cited by 1
- K871407: Meconium Aspirator (1987), cited by 1
- K833375: Dual Purpose Catheter (1984), cited by 1
- K872621: Trach Care Catheter (1987), cited by 1
- K964369: Trach Care Set with Microban (1997), cited by 1
- K760371: Vent-O2-Cath (1976), cited by 1
- K811241: Bodai Suction -Safe 4 (1981), cited by 1
- K955831: Argyle Aspr-Care Closed Suction System (1996), cited by 1
- K842166: Intermed, Ins Sterile Water/Saline (1985), cited by 1

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