NXSTAGE SYSTEM ONE— 510(k) K140526
Substantially EquivalentNxstage Medical, Inc.
FDA 510(k) clearance K140526 for NXSTAGE SYSTEM ONE, Substantially Equivalent on 2014-05-19. Applicant: Nxstage Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Nxstage Medical, Inc.
- 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
- Traditional
- Location
- Lawrence, MA, US
Recent devices under product code KDI
view allMore clearances from Nxstage Medical, Inc.
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 K140526
K-number listed on FDA's recall record- Z-0336-2016 — NxStage System One S Cycler - Model no. NX1000-3-A (OUS). For home hemodialysis.
- Z-0337-2016 — NxStage System One S Cycler -High Permeability Hemodialysis System Model no. NX1000-4
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K140526.
Data sourced from openFDA. This site is unofficial and independent of the FDA.