# BSJ: Mask, Gas, Anesthetic

- Device class: 1; regulation: 21 CFR 868.5550; FDA's rule: 510(k) exempt
- FDA decisions: 51
- Recalls: 1 (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)
- 1986: 5
- 1987: 3
- 1988: 5
- 1989: 4
- 1990: 2
- 1992: 1
- 1993: 2
- 1994: 2
- 1995: 6
- 2017: 1

## Most-cited predicates
- K950771: Disposable Adhesive Face Mask (1995), cited by 2
- K871851: Ribbed Cushion Mask (1987), cited by 1
- K163277: SuperNO2VA Device (2017), cited by 1
- K801251: Non-Conductive, Single Use Face Mask #55 (1980), cited by 1
- K953107: Anesthesia/Respiratory Face Mask (1995), cited by 1

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