# PBX: Massager, Vacuum, Radio Frequency Induced Heat

- Device class: 2; regulation: 21 CFR 878.4400; FDA's rule: 510(k) required
- FDA decisions: 81
- 510(k) review time 2021–2025: median 186 days (middle half 121–306)
- Recalls: 1 (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: 6
- 2018: 3
- 2019: 8
- 2020: 8
- 2021: 6
- 2022: 7
- 2023: 9
- 2024: 6
- 2025: 7
- 2026: 6

## Most-cited predicates
- K150035: V10 system (2015), cited by 10
- K162828: Winback Back 3SE (2017), cited by 7
- K143554: Venus Legacy CX (2015), cited by 7
- K161458: Indiba Diathermia Radiofrequency Device - Activ; Indiba Diathermia Radiofrequency Device - Deep Care (2016), cited by 6
- K210877: Evolve System with the T3 Applicator (2021), cited by 5
- K133739: Trusculpt (2014), cited by 5
- K210867: NuEra Tight RF, NuEra Tight RF Plus (2021), cited by 4
- K200241: TempSure System (2020), cited by 4
- K143040: Exilis XP (2015), cited by 4
- K132949: Pellefirm (2014), cited by 4

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