# K131157: Ranfac Bone Marrow Aspiration Needle

- Pathway: 510(k) (Traditional)
- Applicant: Ranfac, Corp.
- Decided: Oct 22, 2013 after 181 days
- Product code: KNW (Instrument, Biopsy)
- Device class: 2
- Regulation: 21 CFR 876.1075
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K871390 (1987). 25 ancestors in all.
12 later devices descend from it; 9 cite it directly.
1 of 38 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050795: Imbibe Bone Marrow Aspiration Needle, Orthovita, Inc. (2005) Summary page 2.
- K100665: Marromax B One Marrow Aspiration Needle Kit, Models 50083-XX, 50084-XX, Needle Tech Products, Inc. (2010) Summary page 2.
- K051506: Mielo-Can, Best-Lisas, Ben - Bone Biopsy.  Fast-Cut, Colt, Spring-Cut, Bio-Cut - Soft Tissue Biopsy, Sterylab S.R.L. (2005) Summary page 2.

## Most influential descendants
- 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
- K202287: Ran-Flex-B Bone Marrow Aspiration Needle (2020), 1 descendant of its own

## Indications for use
The Ranfac Bone Marrow Aspiration Needle Is Intended for use In aspirating bone marrow.

Source page: https://510kreport.com/device/K131157
Methodology: https://510kreport.com/methodology