Asahi Rexeed-Sx/Lx Series Dialyzer
FDA 510(k) K121409 · Asahi Kasei Medical Co., Ltd.
510(k) numberK121409
Submission
- Device name
- Asahi Rexeed-Sx/Lx Series Dialyzer
- Applicant
- Asahi Kasei Medical Co., Ltd.
Charlestown, NH, US - Received
- May 11, 2012
- Decision date
- February 6, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KDI – Dialyzer, High Permeability With Or Without Sealed Dialysate System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5860
- Specialty
- Gastroenterology, Urology
- Life-sustaining
- Yes
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| K253412 | Tablo Hemodialysis System (PN-0008000, PN-0006000U)KDI · Traditional | Outset Medical, Inc. | 01/26/2026SE |
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| K243920 | Purema H Hemoconcentrator - PediatricKDI · Traditional | Medica USA, Inc. | 09/19/2025SE |
| K250508 | AK 98 Dialysis Machine (955607)KDI · Traditional | Vantive US Healthcare, LLC | 08/01/2025SE |
| K243237 | 2008T HD SYS. CDX BLUESTAR (191124); 2008T HD SYS. CDX W/bibag BLUESTAR (191126); 2008T…KDI · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 06/13/2025SE |
| K243505 | 5008X Hemodialysis SystemKDI · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 05/30/2025SE |
More from Fresenius Medical Care Renal Therapies Group, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K162248 | Asahi ViE-U Series DialyzerKDI · Traditional | 05/03/2017SE |
| K153344 | Asahi REXEED-S Series DialyzerKDI · Special | 12/17/2015SE |
| K082515 | Asahi Rexeed-Sx/Lx Dialyzers, Models: 13SX, 15SX, 18SX, 21SX, 25SX, 13LX, 15LX, 18LX, 21LXKDI · Special | 10/03/2008SE |
| K051187 | Rexeed Series DialyzersKDI · Special | 06/08/2005SE |
Questions and answers
When was Asahi Rexeed-Sx/Lx Series Dialyzer cleared by the FDA?
Asahi Rexeed-Sx/Lx Series Dialyzer (K121409) received a 510(k) decision of Substantially Equivalent on February 6, 2013, 271 days after the submission was received.
What is the product code of K121409?
The FDA product code is KDI – Dialyzer, High Permeability With Or Without Sealed Dialysate System, a Class II (moderate risk) device regulated under 21 CFR 876.5860.