# K192099: MED-I Bone Marrow Aspiration Needle, MED-S Bone Marrow Aspiration Needle, MED-L Bone Marrow Biopsy and Aspiration System, MED-B Bone Marrow Biopsy System, MED-J Bone Marrow Biopsy and Aspiration System

- Pathway: 510(k) (Traditional)
- Applicant: Medax Srl Unipersonale
- Decided: Apr 2, 2020 after 241 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: 5 generations back to K890925 (1989). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181803: Medax Biopsy Systems III, Medax Srl Unipersonale (2018) Summary page 6.
- K172344: Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK), Medax Srl Unipersonale (2017) Summary page 6.
- 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 6.

## Indications for use
MED-I Bone Marrow Aspiration Needle: MED-I biopsy system has been designed to be used in bone marrow aspiration procedures from iliac crest or sternum. MED-S Bone Marrow Aspiration Needle: MED-S biopsy system has been designed to be used in bone marrow aspiration procedures from sternum or iliac crest. MED-L Bone Marrow Biopsy and Aspiration System: MED-L biopsy system has been designed to be used in bone marrow aspiration and the posterior iliac crest biopsy. MED-B Bone Marrow Biopsy System: MED-B biopsy system has been designed to be used in bone marrow aspiration and the posterior iliac crest biopsy. MED-J Bone Marrow Biopsy and Aspiration System: MED-J biopsy system has been designed to be used in bone marrow aspiration and the posterior iliac crest biopsy. Note: Do not use in sternal procedure.

Source page: https://510kreport.com/device/K192099
Methodology: https://510kreport.com/methodology