# JOW: Sleeve, Limb, Compressible

- Device class: 2; regulation: 21 CFR 870.5800; FDA's rule: 510(k) required
- FDA decisions: 354
- 510(k) review time 2021–2025: median 139 days (middle half 91–193)
- Recalls: 16 (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)
- 2017: 9
- 2018: 11
- 2019: 11
- 2020: 14
- 2021: 16
- 2022: 7
- 2023: 6
- 2024: 8
- 2025: 7
- 2026: 6

## Most-cited predicates
- K881632: Flowtron DVT System AC500 Pump, L501 Garment (1988), cited by 10
- K061866: Nanotherm,  Vascutherm and Prothermo Therapy Wraps (2006), cited by 9
- K040511: SCD Express Portable Compression System (2004), cited by 9
- K043423: Model SC-3008 Sequential Circulator (2005), cited by 9
- K061125: Dvtcare CA5 (2006), cited by 8
- K011318: Venodyne DVT Advantage Plus (2001), cited by 8
- K981311: Cowboy XV (1999), cited by 8
- K882683: Jobst Extremity Pump (R) System 7500 (1988), cited by 7
- K133274: Vena Pro (2014), cited by 7
- K944567: Cowboy X (1995), cited by 7

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