# JOH: Tube Tracheostomy And Tube Cuff

- Device class: 2; regulation: 21 CFR 868.5800; FDA's rule: 510(k) required
- FDA decisions: 109
- 510(k) review time 2021–2025: median 252 days (middle half 249–257)
- Recalls: 114 (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)
- 2013: 3
- 2014: 3
- 2015: 3
- 2016: 1
- 2017: 1
- 2018: 3
- 2019: 2
- 2020: 1
- 2021: 2
- 2025: 1

## Most-cited predicates
- K962173: Shikey Tracheostomy Tubes and Accessories (1996), cited by 5
- K083641: Bivona Tracheostomy Tubes (2009), cited by 4
- K980466: Per-Fit Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy Tube and Disposable Inner Cannula (1998), cited by 4
- K011210: The Percuquick Set for Percutaneous Dilation Tracheostomy (2001), cited by 3
- K041348: Portex Ultraperc Percutaneous Dilation Tracheostomy Kit_with Serial Dilators or Single Stage Dilator, Blue Line Ultra (2004), cited by 3
- K962175: Portex Adjustable Flange Tracheostomy Tube (1997), cited by 3
- K022212: Portex Percutaneous Dilatational Tracheostomy Kits (2003), cited by 3
- K961449: Tracheostomy Tubes Tracoe-Flex (1996), cited by 2
- K936133: Percutaneous Tracheostomy Kit (1994), cited by 2
- K133597: Ciaglia Percutaneous Tracheostomy Introducer Set/Tray, Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Set/Tray (2014), cited by 2

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