# QPB: System, Suction, Lipoplasty For Removal

- Device class: 2; regulation: 21 CFR 878.5040; FDA's rule: 510(k) required
- FDA decisions: 60
- 510(k) review time 2021–2025: median 194 days (middle half 128–276)
- Recalls: 0 (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: 1
- 2015: 1
- 2016: 1
- 2017: 3
- 2019: 2
- 2020: 2
- 2022: 2
- 2024: 4
- 2025: 2
- 2026: 5

## Most-cited predicates
- K981172: Lipoplasty/ Liposuction Aspiration and Tumescent Infusion Cannulae and Needles (1998), cited by 8
- K981215: Psi-Tec Liposuction Aspirator (1998), cited by 5
- K053451: Liposat (Infiltration Pump), Model 00 002 274; Vacusat (Suction Unit), Model 00 002 252 (220 V), 00 002 318 (110 V); (2006), cited by 5
- K060089: Tulip Disposable Cannulas (2006), cited by 4
- K022051: Soundvaser System (2002), cited by 4
- K981922: Light Duty Pneumatic Instrument Model Number Pad-100, Heavy Duty Pneumatic Instrument Model Pad-200, Light Duty Electri (1998), cited by 4
- K032802: HK Liposuction Aspirator, Model AP-Iii & AP230-Iii (2003), cited by 4
- K212024: PAL System (2022), cited by 3
- K113795: Suction Lipolasty Accessories (2012), cited by 3
- K042261: Macropore Puricel Lipoplasty System (2004), cited by 3

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