# K140991: Ranfac Aspiration Needle with Adjustable Guide

- Pathway: 510(k) (Traditional)
- Applicant: Ranfac, Corp.
- Decided: Sep 11, 2014 after 147 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: 7 generations back to K871390 (1987). 30 ancestors in all.
5 later devices descend from it; 1 cites it directly.
1 of 36 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131157: Ranfac Bone Marrow Aspiration Needle, Ranfac, Corp. (2013) Summary page 5.
- K121181: Swannshidi Bone Marrow Aspiration Needle, Alliance Partners, LLC (2012) Summary page 5.

## Most influential descendants
- K150563: Marrow Cellution Bone Marrow Aspiration Needle (2015), 4 descendants 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
- K260572: Marrow Marxman (2026), 0 descendants of its own
- K203397: Marrow-Pack (white)- 11gauge/10cm or 13gauge/10cm, Marrow-Tray (red)- 11gauge/10cm or 13gauge/10cm, Marrow-Set (violet)- 11gauge/10cm or 13gauge/10cm,  Marrow-kit (grey)- 11gauge/10cm or 13gauge/10cm, Marrow-Stem (green)- 11gauge/10cm or 13gauge/10cm (2021), 0 descendants of its own

## Indications for use
The Ranfac Aspiration Needle with Adjustable Guide is intended for use for aspiration of bone marrow or autologous blood using a standard piston syringe.

Source page: https://510kreport.com/device/K140991
Methodology: https://510kreport.com/methodology