# DJZ: Devices, Breath Trapping, Alcohol

- Device class: 1; regulation: 21 CFR 862.3050; FDA's rule: 510(k) exempt
- FDA decisions: 28
- Recalls: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2004: 1
- 2005: 2
- 2006: 6
- 2007: 2
- 2008: 5
- 2009: 5
- 2010: 2
- 2011: 3
- 2013: 1
- 2016: 1

## Most-cited predicates
- K041334: Alcomate, Model CA2000 (2004), cited by 7
- K052448: Pocket Breathalyzer. Connectables (2006), cited by 4
- K080848: Alcohawk Model PT500 Digital Alcohol Detector (2008), cited by 4
- K060761: Breathscan, Breath and Breath Check Alcohol Detectors (2006), cited by 3
- K043188: Alcohawk Precision (2005), cited by 2
- K063443: Draeger Alcotest 6510 (2008), cited by 1
- K053332: Breath Alcohol Test System, Model AL 2500 (2006), cited by 1
- K061922: Breath Alcohol Test System, Model AL-5000 (2006), cited by 1
- K052804: Breathkey Model G10/Breathkey Model G30X (2005), cited by 1
- K062971: Breath Alcohol Check .02  and Breathscan .02 Detection Systems (2006), cited by 1

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