# KNW: Instrument, Biopsy

- Device class: 2; regulation: 21 CFR 876.1075; FDA's rule: 510(k) required
- FDA decisions: 365
- 510(k) review time 2021–2025: median 158 days (middle half 106–215)
- Recalls: 57 (4 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: 8
- 2018: 7
- 2019: 5
- 2020: 8
- 2021: 9
- 2022: 8
- 2023: 7
- 2024: 5
- 2025: 12
- 2026: 7

## Most-cited predicates
- K133948: Bard (R) Monopty (R) Disposable Core Biopsy Instrument, Bard (R) Max-Core (R) Disposable Core Instrument (2014), cited by 13
- K131157: Ranfac Bone Marrow Aspiration Needle (2013), cited by 9
- K003297: Mammotome Hand Held Probe, Model MHH8 (2001), cited by 8
- K991980: Mammotome HH Hand-Held Probe, Vacuum Set, Control Module, HH Hand-Held Holster and Cables, Software Package, Footswitch, (1999), cited by 6
- K033700: Mammotome EX Hand Held System (2004), cited by 5
- K980196: MD Tech Biopsy Set for Bone and Bone Marrow (1998), cited by 5
- K914874: Manan Pro-Mag Automatic Biopsy Device (1992), cited by 5
- K974814: Manan (TM) Super-Core Biopsy Needles (1998), cited by 5
- K980122: Manan Soft Tissue Biopsy Needles (1998), cited by 5
- K050795: Imbibe Bone Marrow Aspiration Needle (2005), cited by 5

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