# BYD: Condenser, Heat And Moisture (Artificial Nose)

- Device class: 1; regulation: 21 CFR 868.5375; FDA's rule: 510(k) exempt
- FDA decisions: 73
- Recalls: 10 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1987: 5
- 1988: 5
- 1989: 2
- 1990: 8
- 1991: 6
- 1992: 2
- 1993: 7
- 1994: 10
- 1995: 18
- 1996: 1

## Most-cited predicates
- K903058: Bact-Hme (TM) (1990), cited by 3
- K952084: Humid-Vent Filter Pedi (1995), cited by 1
- K945359: Aqua+I-F, I-H, I-FH, II-H, II-FH, Iii-H (1995), cited by 1
- K941585: Hygroster (1994), cited by 1
- K954194: Disposable Hme/Filter (1995), cited by 1
- K914336: Breathe Easy (1992), cited by 1
- K881657: Humid-Vent Filter (1988), cited by 1
- K952845: Humid-Vent Trach-Vent (1995), cited by 1
- K915786: Blom-Singer Humid/Fil Syst Inhealth in-Line Humid. (1992), cited by 1

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