# K100665: Marromax B One Marrow Aspiration Needle Kit, Models 50083-XX, 50084-XX

- Pathway: 510(k) (Abbreviated)
- Applicant: Needle Tech Products, Inc.
- Decided: Jun 24, 2010 after 108 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
13 later devices descend from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K131157: Ranfac Bone Marrow Aspiration Needle (2013), 12 descendants of its own
- K140991: Ranfac Aspiration Needle with Adjustable Guide (2014), 5 descendants of its own
- K150563: Marrow Cellution Bone Marrow Aspiration Needle (2015), 4 descendants of its own
- K240664: ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) (2024), 1 descendant of its own
- K223612: Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA) (2023), 1 descendant of its own

## Indications for use
The MARLROWMAX Bone Marrow Aspiration Needle is a stylet/cannula system to be used to obtain bone marrow and/or autologous blood from patients intraoperatively by use of a syringe.

Source page: https://510kreport.com/device/K100665
Methodology: https://510kreport.com/methodology