# K940025: Manan Bone Marrow Harvest Needles

- Pathway: 510(k) (Traditional)
- Applicant: Manan Medical Products, Inc.
- Decided: Feb 25, 1994 after 53 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.
42 later devices descend from it; 2 cite it directly.
1 of 43 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, 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
- K050795: Imbibe Bone Marrow Aspiration Needle (2005), 19 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

Source page: https://510kreport.com/device/K940025
Methodology: https://510kreport.com/methodology