# LWE: Bone Marrow Collection/Transfusion Kit

- Device class: 2; regulation: 21 CFR —
- FDA decisions: 3
- 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)
- 1987: 1
- 1991: 1
- 1995: 1

## Most-cited predicates
- K952350: Jamshidi Style Biopsy Needle (Acri) (Biomid), Illinois Style Biopsy Needle (Isan) (1995), cited by 1
- K913306: Bone-Temno/Sternum-Temno (1991), cited by 1

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