# K945109: Monoject Bone Marrow Biopsy Trays

- Pathway: 510(k) (Traditional)
- Applicant: Sherwood Medical Co.
- Decided: Nov 14, 1994 after 27 days
- Product code: GAA (Needle, Aspiration And Injection, Disposable)
- Device class: 1
- Regulation: 21 CFR 878.4800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
36 later devices descend from it; 1 cites it directly.
1 of 37 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K961959: MD Tech Biopsy Set for Bone and Bone Marrow (1996), 35 descendants of its own
- K980196: MD Tech Biopsy Set for Bone and Bone Marrow (1998), 34 descendants of its own
- K051506: Mielo-Can, Best-Lisas, Ben - Bone Biopsy.  Fast-Cut, Colt, Spring-Cut, Bio-Cut - Soft Tissue Biopsy (2005), 18 descendants of its own
- K062833: Powered EZ-IO Bone Marrow Aspiration System (2006), 14 descendants of its own
- K043523: Interv Brand Snarelok Bone Marrow Biopsy Needle (2005), 14 descendants of its own

Source page: https://510kreport.com/device/K945109
Methodology: https://510kreport.com/methodology