# K181803: Medax Biopsy Systems III

- Pathway: 510(k) (Traditional)
- Applicant: Medax Srl Unipersonale
- Decided: Oct 18, 2018 after 105 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
No predicates in its family tree.
4 later devices descend from it; 3 cite it directly.
0 of 5 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
- K192101: Medone Ultra, Medextra (2020), 2 descendants of its own
- K210946: Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy Devices, Promisemed Semi-automatic Biopsy Needles (2021), 1 descendant of its own
- K261196: Promisemed VeriEcto Automatic Biopsy Needles (2026), 0 descendants of its own
- 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 (2020), 0 descendants of its own

## Indications for use
MEDEASY, UNIVERSAL DUO, VELOX, VELOX 2, UNIVERSAL PLUS, UNIVERSAL, LUX, LUX 2, FACILE, CAESAR biopsy needle is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, breast, spleen, lymph nodes and various soft tissue masses. It is not intended for use in bone biopsy NEO OXUS, HEMAX biopsy needle must be used for bone marrow aspiration and the posterior iliac crest biopsy PERFECTUS, HANDLEX biopsy needle must be used for bone marrow aspiration from sternum or iliac crest HEPAX biopsy needle is intended for use in obtaining histological and cytological biopsies of soft tissues. It is not intended for use in bone biopsy. FNA (Chiba/Quincke/Turner/Westcott/Franseen) biopsy needles is intended for use in obtaining biopsies from soft tissues such as thyroid, liver, breast, spleen, abdomen, pancreas, lungs, lymph nodes and various soft tissue masses. It is not intended for use in bone biopsy.

Source page: https://510kreport.com/device/K181803
Methodology: https://510kreport.com/methodology