# B. Braun Avitum AG

- Location (FDA's records): Allentown, PA
- FDA decisions: 6 (1997–2017): 5 510(k) clearances and 1 original PMA approval
- Product codes: KDI (4), KPO (1), MMY (1)
- Predicates its devices cite: 5 (1 its own); citations of its devices by later devices: 4 (1 its own)
- Recalls linked to its devices: 8 (6 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- B. Braun Medizintechnologie GmbH: 4 (https://510kreport.com/company/b-braun-medizintechnologie)

## Firms that cite its devices most
- Di-Chem, Inc.: 1 (https://510kreport.com/company/di-chem)
- Nikkiso CO., LTD.: 1 (https://510kreport.com/company/nikkiso)
- Nipro Medical Corporation: 1 (https://510kreport.com/company/nipro-medical)

## Its most-cited devices
- K083460: Dialog with Adimea Option (2010), cited by 2
- K100334: Diacap Polysulfone Hiflo 23 Hemodilayzer , Model 72036811 (2010), cited by 1
- K102194: Solcart B (2011), cited by 1

## Recent decisions
- K170574: Diacap Pro Dialyzer (Aug 11, 2017)
- K143482: xevonta dialyzer (Mar 1, 2016)
- K102194: Solcart B (Apr 25, 2011)
- K100334: Diacap Polysulfone Hiflo 23 Hemodilayzer , Model 72036811 (Apr 22, 2010)
- K083460: Dialog with Adimea Option (Feb 18, 2010)
- P940016: H.E.L.P. System (Sep 19, 1997)

Source page: https://510kreport.com/company/b-braun-avitum
