ASAHI REXEED-SX/LX DIALYZERS, MODELS: 13SX, 15SX, 18SX, 21SX, 25SX, 13LX, 15LX, 18LX, 21LX— 510(k) K082515
Substantially EquivalentAsahi Kasei Medical Co., Ltd.
FDA 510(k) clearance K082515 for ASAHI REXEED-SX/LX DIALYZERS, MODELS: 13SX, 15SX, 18SX, 21SX, 25SX, 13LX, 15LX, 18LX, 21LX, Substantially Equivalent on 2008-10-03. Applicant: Asahi Kasei Medical Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Asahi Kasei Medical Co., Ltd.
- Product code
- Code KDI
- Device class
- Class 2
- Regulation
- 21 CFR 876.5860
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Rockville, MD, US
Recent devices under product code KDI
view allMore clearances from Asahi Kasei Medical Co., Ltd.
view allAdverse events under product code KDI
product code KDI- Death
- 352
- Injury
- 1,474
- Malfunction
- 12,534
- Other
- 4
- Total
- 14,364
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K082515
K-number listed on FDA's recall record- Z-2418-2012 — Asahi KASEI, REXEED(TM)- 15 SX, HEMODIALYZER dialysis filter
- Z-2419-2012 — Asahi KASEI, REXEED(TM)- 18 SX, HEMODIALYZER dialysis filter
- Z-2420-2012 — Asahi KASEI, REXEED(TM)- 21 SX, HEMODIALYZER dialysis filter
- Z-2421-2012 — Asahi KASEI, REXEED(TM)- 25 SX, HEMODIALYZER dialysis filter
- Z-2422-2012 — Asahi KASEI, REXEED(TM)- 13 LX, HEMODIALYZER dialysis filter
- Z-2423-2012 — Asahi KASEI, REXEED(TM)- 15 LX, HEMODIALYZER dialysis filter
- Z-2424-2012 — Asahi KASEI, REXEED(TM)- 18 LX, HEMODIALYZER dialysis filter
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K082515.
Data sourced from openFDA. This site is unofficial and independent of the FDA.