# CAN: Regulator, Pressure, Gas Cylinder

- Device class: 1; regulation: 21 CFR 868.2700; FDA's rule: 510(k) exempt
- FDA decisions: 55
- Recalls: 12 (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)
- 1989: 5
- 1990: 6
- 1991: 1
- 1992: 4
- 1993: 1
- 1994: 1
- 1995: 2
- 2006: 2
- 2009: 1
- 2017: 1

## Most-cited predicates
- K901831: Precision Medical Oxygen Regulator (1990), cited by 1
- K852649: Pressure Regulator/Y Connector (1985), cited by 1
- K950777: Oxygen Regulator (1995), cited by 1
- K780359: Oxygen Regulator/Flowmeter (1978), cited by 1
- K061785: Cyl-Fil Oxygen System (2006), cited by 1
- K891771: Victor Medical Oxygen Therapy Regulator, Modified (1989), cited by 1

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