# Medax Srl Unipersonale

- Location (FDA's records): Poggio Rusco, IT
- FDA decisions: 6 (2011–2020): 6 510(k) clearances
- Names in FDA's records: Medax Srl Unipersonale (5); Medax Unipersonale Srl (1)
- Product codes: KNW (6)
- 510(k) review time since 2016: median 173 days, against 91 for FDA's reviews in the same codes and years (0 of 4 faster)
- Predicates its devices cite: 9 (5 its own); citations of its devices by later devices: 7 (5 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Care Fusion: 2 (https://510kreport.com/company/care-fusion)
- Bard Peripheral Vascular, Inc.: 1 (https://510kreport.com/company/bard-peripheral-vascular)
- Biopsybell S.R.L.: 1 (https://510kreport.com/company/biopsybell)

## Firms that cite its devices most
- Promisemed Hangzhou Meditech Co., Ltd.: 2 (https://510kreport.com/company/promisemed-hangzhou-meditech)

## Its most-cited devices
- K181803: Medax Biopsy Systems III (2018), cited by 3
- K142125: New Medax Biopsy Systems (2015), cited by 1
- K172344: Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK) (2017), cited by 1
- K192101: Medone Ultra, Medextra (2020), cited by 1
- K092338: Medax Unipersonale SRL (2011), cited by 1

## Recent decisions
- K192101: Medone Ultra, Medextra (Apr 2, 2020)
- 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 (Apr 2, 2020)
- K181803: Medax Biopsy Systems III (Oct 18, 2018)
- K172344: Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK) (Nov 13, 2017)
- K142125: New Medax Biopsy Systems (Dec 22, 2015)
- K092338: Medax Unipersonale SRL (May 27, 2011)

Source page: https://510kreport.com/company/medax-unipersonale