# IRP: Massager, Powered Inflatable Tube

- Device class: 2; regulation: 21 CFR 890.5650; FDA's rule: 510(k) required
- FDA decisions: 158
- 510(k) review time 2021–2025: median 131 days (middle half 65–236)
- Recalls: 3 (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: 4
- 2018: 3
- 2019: 10
- 2020: 9
- 2021: 19
- 2022: 14
- 2023: 10
- 2024: 12
- 2025: 13
- 2026: 12

## Most-cited predicates
- K182668: Rapid Reboot Compression Therapy System (2018), cited by 16
- K193354: Air Compression Therapy Device (2020), cited by 9
- K160608: NormaTec Pulse and NormaTec Pulse Pro (2016), cited by 8
- K171685: Med4 Elite (2017), cited by 8
- K030437: Relaxor Perfect Touch Air Massaging System (2003), cited by 7
- K013061: Biotouch Massage Therapy System (2002), cited by 5
- K193550: Therm-X (2020), cited by 5
- K102320: Compressible Limb and Circulation Therapy System Model LX7(V7) (2011), cited by 4
- K072620: Game Ready Classic System, Model 550550 (2007), cited by 4
- K240122: Normatec Elite (2024), cited by 3

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