# BSP: Needle, Conduction, Anesthetic (W/Wo Introducer)

- Device class: 2; regulation: 21 CFR 868.5150; FDA's rule: 510(k) required
- FDA decisions: 152
- 510(k) review time 2021–2025: median 176 days (middle half 95–271)
- Recalls: 9 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2015: 2
- 2016: 6
- 2017: 4
- 2018: 8
- 2019: 2
- 2020: 3
- 2021: 3
- 2022: 2
- 2024: 3
- 2025: 4

## Most-cited predicates
- K040965: Pajunk Tuohy Needles, Quincke Needles, Chiba Needles & Crawford Needles (2004), cited by 11
- K000722: Unipolar Needles (2000), cited by 9
- K113207: Sono Tap, Tuohy Sono (2012), cited by 7
- K023218: Modification to Plexolong Sets (2003), cited by 6
- K911260: Atraumatic Standard Sprotte Needle (1991), cited by 5
- K911221: Atraumatic Special Sprotte Needle (1992), cited by 5
- K911202: Atraumatic Standard Sprotte Needle (1992), cited by 5
- K041843: Pencil Point Needle (2004), cited by 3
- K160294: SPROTTE NRFit, Quincke NRFit Lumbar Puncture needles (2016), cited by 3
- K100241: Contiplex D Continuous Nerve Block Set, Model 331687, 331686, 331685, 331680 (2010), cited by 3

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