# JCX: Apparatus, Suction, Ward Use, Portable, Ac-Powered

- Device class: 2; regulation: 21 CFR 878.4780; FDA's rule: 510(k) required
- FDA decisions: 77
- 510(k) review time 2021–2025: median 28 days (middle half 26–108)
- Recalls: 12 (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)
- 2014: 4
- 2016: 2
- 2017: 2
- 2018: 2
- 2019: 3
- 2022: 1
- 2023: 1
- 2024: 1
- 2025: 2
- 2026: 1

## Most-cited predicates
- K982304: Devilbiss Suction Unit (1998), cited by 8
- K122756: Penumbra Pump Max (110VAC), Penumbra Pump Max (230VAC), Penumbar Pump Max Canister/Tubing (2012), cited by 8
- K945062: Vacplus (1995), cited by 4
- K132671: Stryker Neptune 2 Waste Managment System (2013), cited by 3
- K060277: Boehringer Laboratories Suction Pump System (2006), cited by 3
- K801043: E-Vax Chest Drainage System (1980), cited by 3
- K011725: Olympus Suction Pump, Model KV-5 (2001), cited by 3
- K082762: Aardvark Nasal Irrigation and Aspiration Device (2008), cited by 2
- K895761: General Asperator (1989), cited by 2
- K935218: Schuco-Vac Model 178 (1994), cited by 2

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