Chrysalis Intelligence · Sponsors · Nxstage Medical, Inc.

Nxstage Medical, Inc.

Lawrence, MA, US · 3 510(k) clearances · 2 recalls

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Total clearances
3
2023-08-11 → 2024-03-14
Last 12 months
0
Product codes
2
Most recent
2024-03-14
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System Class II Gastroenterology, Urology 2 2024-03-14
KPO — — — 1 2024-01-18
Safety

Recalls (2)

Class I (serious)
0
Risk of injury / death
Total recalls
2
Currently ongoing
2
Most recent
2025-04-28
DateSeverityStatusRecall # ProductCodeReason
2025-04-28 Class II Ongoing Z-1864-2025 NxStage PureFlow-B Solution. Catalog numbers: RFP-400, RFP-401, RFP-402, RFP-403, RFP-404, RFP-406, RFP-453, RFP-454, RF… — Potential for the perimeter seal on the small chamber of the two-chamber bag to fail causing the electrolyte fluid to splash into the face of the user when atte…
2024-05-14 Class II Ongoing Z-2160-2024 NxStage PureFlow-B Solution, Premixed Dialysate for Hemodialysis, Device Catalog Numbers RFP-400, RFP-401, RFP-402, RFP-… — The smaller chamber of the two chamber bag is bursting when nurses are attempting to mix the two chambers prior to use. The electrolyte fluid in the small chamb…
Filings

All 510(k) clearances (3)

Date K-number Device Code Class Specialty
2024-03-14 K232803 NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E) KDI Class II Gastroenterology, Urology
2024-01-18 K233213 NxStage PureFlow Solution KPO — —
2023-08-11 K230632 VersiHD with GuideMe software KDI Class II Gastroenterology, Urology
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence