# K190177: J-Type Marrow Biopsy Needle,T-Type Marrow Biopsy Needle,Tweezer Bone Marrow Biopsy Needle,

- Pathway: 510(k) (Special)
- Applicant: Ranfac Corporation
- Decided: Jun 12, 2019 after 131 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). 36 ancestors in all.
No later device cites it as a predicate yet.
1 of 37 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 4.
- K983187: Medsol Goldenberg Bone Marrow Biopsy Needle, Medsol Corp. (1998) Summary page 4.
- K171531: Jamshidi Bone Marrow Biopsy/Aspiration Needle, Jamshidi T-Handle Bone Marrow Biopsy/Aspiration Needle, Jamshidi Evolve Bone Marrow Biopsy/Aspiration Needle, Care Fusion (2017) Summary page 4.

## Indications for use
The Ranfac Bone Marrow Biopsy Needles are indicated for use in aspirating bone marrow and for use in obtaining core biopsy samples of bone marrow.

Source page: https://510kreport.com/device/K190177
Methodology: https://510kreport.com/methodology