# BTA: Pump, Portable, Aspiration (Manual Or Powered)

- Device class: 2; regulation: 21 CFR 878.4780; FDA's rule: 510(k) required
- FDA decisions: 160
- 510(k) review time 2021–2025: median 127 days (middle half 53–175)
- Recalls: 17 (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)
- 2016: 3
- 2017: 1
- 2018: 4
- 2020: 1
- 2021: 1
- 2022: 3
- 2023: 4
- 2024: 5
- 2025: 6
- 2026: 7

## Most-cited predicates
- K983552: Basic, Median, Dominant, and Vario (1999), cited by 9
- K021368: Medela Basic 30 and Dominant 50 Suction Pumps, Models 037, 057 (2002), cited by 8
- K061205: Medela Vario 8/18/CI Secretion & Surgical Aspirator (2006), cited by 5
- K222547: Electric nasal aspirator (2022), cited by 5
- K980392: Psi-Tec Aspirator (1998), cited by 3
- K840110: Laerdal Suction Unit (1984), cited by 3
- K140179: Easy GO Vac (2014), cited by 3
- K971749: Easygo Aspirator (1998), cited by 3
- K043544: Medela Dominant 35 C/I Secretion and Surgical Aspirator (2005), cited by 3
- K090379: Avita Nasal Aspirator, Model, NS1 Series (2010), cited by 3

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