# EMX: Balloon, Epistaxis

- Device class: 1; regulation: 21 CFR 874.4100; FDA's rule: 510(k) exempt
- FDA decisions: 47
- 510(k) review time 2021–2025: median 283 days (middle half 283–283)
- Recalls: 4 (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)
- 1993: 3
- 1994: 3
- 1995: 6
- 1996: 4
- 1997: 9
- 1998: 1
- 1999: 3
- 2000: 2
- 2004: 1
- 2022: 1

## Most-cited predicates
- K982731: Merogel Nasal Dressing and Sinus Stent (1999), cited by 7
- K984069: Entaxis Nasal Packing (1999), cited by 4
- K972459: Rhinocell Nasal Packings (1997), cited by 2
- K920394: Merocel Epistacis Kit (1993), cited by 2
- K993362: Hylasine (2000), cited by 2
- K983276: Hydrofera Bacteristatic Nasal Dressing (1999), cited by 2
- K935724: The Expandacell Sinus Pack (1994), cited by 1
- K900171: Expandacel Nasal Tampons (1990), cited by 1
- K920358: Ultracell Nasal Packing (1992), cited by 1
- K972077: Epi-Stop Epistaxis Catheter (1997), cited by 1

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