# BTI: Compressor, Air, Portable

- Device class: 2; regulation: 21 CFR 868.6250; FDA's rule: 510(k) exempt
- FDA decisions: 74
- Recalls: 5 (3 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2001: 3
- 2002: 1
- 2003: 2
- 2004: 4
- 2005: 2
- 2006: 1
- 2008: 1
- 2009: 1
- 2012: 1
- 2013: 1

## Most-cited predicates
- K922623: Nebulizer System (1992), cited by 3
- K002862: Proneb Ultra Model Number 85B0100 (2001), cited by 3
- K982789: Medical Air Compressor, Model # 8413419 (1998), cited by 2
- K023354: Compressor Mini, 115 V, Model 64 81 779 EH81E (2003), cited by 2
- K931015: Devilbiss Model 4650 Compressor Neubulizer (1993), cited by 2
- K013027: Mister Neb Nebulizer Compressor, with Nebulizer, Model HS123 (2001), cited by 2
- K041406: Newport C250 Air Compressor Model C250 (2004), cited by 2
- K862628: Bunn Model 510 Medication Compressor (1986), cited by 1
- K920954: Air Star (1992), cited by 1
- K900686: Maxi Compressors (1990), cited by 1

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