# Asahi Kasei Medical Co., Ltd.

- Location (FDA's records): Chiyoda-Ku, JP
- FDA decisions: 6 (1983–2017): 5 510(k) clearances and 1 original PMA approval
- Product codes: KDI (5), MDP (1)
- Predicates its devices cite: 18 (4 its own); citations of its devices by later devices: 5 (4 its own)
- Recalls linked to its devices: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Asahi Medical Co., Ltd.: 10 (https://510kreport.com/company/asahi-medical)
- Terumo Medical Corp.: 2 (https://510kreport.com/company/terumo-medical)
- Fresenius Medical Care North America: 1 (https://510kreport.com/company/fresenius-medical-care-north-america)
- Gambro Renal Products: 1 (https://510kreport.com/company/gambro-renal-products)

## Firms that cite its devices most
- Fresenius Medical Care North America: 1 (https://510kreport.com/company/fresenius-medical-care-north-america)

## Its most-cited devices
- K051187: Rexeed Series Dialyzers (2005), cited by 4
- K082515: Asahi Rexeed-SX/LX Dialyzers, Models: 13SX, 15SX, 18SX, 21SX, 25SX, 13LX, 15LX, 18LX, 21LX (2008), cited by 1

## Recent decisions
- K162248: Asahi ViE-U Series Dialyzer (May 3, 2017)
- K153344: Asahi REXEED-S Series Dialyzer (Dec 17, 2015)
- K121409: Asahi Rexeed-SX/LX Series Dialyzer (Feb 6, 2013)
- K082515: Asahi Rexeed-SX/LX Dialyzers, Models: 13SX, 15SX, 18SX, 21SX, 25SX, 13LX, 15LX, 18LX, 21LX (Oct 3, 2008)
- K051187: Rexeed Series Dialyzers (Jun 8, 2005)
- P820033: Plasmaflo OP-05 W (a) Asahi Plasma Separator (Jul 5, 1983)

Source page: https://510kreport.com/company/asahi-kasei-medical