Home › Device types › FKP
System, Dialysate Delivery, Single Patient
FDA product code FKP · Class 2 · Gastroenterology, Urology
10
Registered devices
1,072
Adverse events
12
Recalls
50
510(k) clearances
Devices with this code
Nx2me Connected Health Nx2me Clinician Portal — NXSTAGE MEDICAL, INC.RenalCheck PX — Ibt Scientific LLCNX2ME APP — NXSTAGE MEDICAL, INC.NX2ME CLINICIAN PORTAL — NXSTAGE MEDICAL, INC.Peracid Test — Ibt Scientific LLCNx2me Connected Health Nx2me App — NXSTAGE MEDICAL, INC.NxStage Dosing Calculator — NXSTAGE MEDICAL, INC.WaterCheckRC — Ibt Scientific LLCWaterCheckCP — Ibt Scientific LLCWaterCheck2 — Ibt Scientific LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2010-01-29 | Baxter Healthcare Renal Div | Some of the 1550 Hemodialysis Instruments may have replacement circuit boards with incorrect versions of software. |
| 2009-11-20 | Fresenius Medical Care North America | Power cords may fail if the prongs crack or fail at the plug, and may become a fire/burn/shock hazard or delay/interrupt therapy. |
| 2009-11-20 | Fresenius Medical Care North America | Power cords may fail if the prongs crack or fail at the plug, and may become a fire/burn/shock hazard or delay/interrupt therapy. |
| 2008-05-23 | Hach Co | Inconsistencies in total chlorine and free chlorine levels may result in providing inaccurate false positive or false negative results |
| 2008-05-23 | Hach Co | Inconsistencies in total chlorine and free chlorine levels may result in providing inaccurate false positive or false negative results |
| 2008-05-23 | Hach Co | Inconsistencies in total chlorine and free chlorine levels may result in providing inaccurate false positive or false negative results |
| 2008-05-23 | Hach Co | Inconsistencies in total chlorine and free chlorine levels may result in providing inaccurate false positive or false negative results |
| 2006-02-24 | Baxter Healthcare Renal Div | The older style 'Through Hardware' Dialysate Monitoring Manifolds and 'Noryl' Ultra Filtration Removal Regulators may become cracked due to mechanical and therm |
| 2003-05-28 | Baxter Healthcare Renal Div | The air detector may not detect air bubbles consistently at the selected limit. |
| 2003-03-20 | Baxter Healthcare Corp. | The dialysis treatment may be run without the bicarbonate due to an undetected bicarbonate pump stall following a sodium change. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.