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FDA 510(k)

NaturaLyte®乾性重碳濃縮液（08-4112-2）

K 號：K253462 · 2026-01-29

申請人Fresenius Medical Care Renal Therapies Group, LLC
決定日期2026-01-29
產品代碼KPO
諮詢委員會GU
決定相當於

器材摘要

NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2) is the device name listed in this FDA 510(k) record. The listed applicant is Fresenius Medical Care Renal Therapies Group, LLC. It received FDA 510(k) clearance on 2026-01-29 under 510(k) number K253462. The device is classified under product code KPO. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2)?

NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2) is a medical device that received FDA 510(k) clearance on 2026-01-29. The listed applicant is Fresenius Medical Care Renal Therapies Group, LLC. The 510(k) number is K253462.

When did NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2) receive FDA 510(k) clearance?

NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2) received FDA 510(k) clearance on 2026-01-29, under 510(k) number K253462.

Who is the listed applicant for NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2)?

FDA 510(k) 記錄中將 Fresenius Medical Care Renal Therapies Group, LLC 列為申請人。這並不單獨確立設備製造商的身份。

What is the FDA product code for NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2)?

The FDA product code for NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2) is KPO.

相關臨床試驗

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 Fresenius Medical Care Renal Therapies Group, LLC 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K261267Careflux H60；Careflux H70；Careflux V500K252377NxStage System One 配 NxViewK252459multiFlux 130 (F00013123)；multiFlux 160 (F00013124)K253518FX珊瑚40；FX珊瑚50K250634BCM2-Body Composition MonitorK250471AquaC UNO H

查看所有 48 項裝置 →

相關器械（代碼：KPO）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K260799尼普羅乾性酸濃縮混合器Nipro Technical Solutions, IncoporatedK252180Bicarby Dialysate RFP-404 (RFP-404-W)；Bicarby Dialysate RFP-403 (RFP-403-W)；Bicarby Dialysate RFP-403 (RFP-403-G)；Bicarby Dialysate RFP-453 (RFP-453-W)；Bicarby Dialysate RFP-453 (RFP-453-G)；Bicarby Dialysate RFP-454 (RFP-454-W)；Bicarby Dialysate RFP-454 (RFP-454-G)；Bicarby Dialysate RFP-456 (RFP-456-W)Fresenius Medical Care Renal Therapies Group, LLCK243786雙碳比透析液 RFP-402 (RFP-402-G)；雙碳比透析液 RFP-400 (RFP-400-G)；雙碳比透析液 RFP-407 (RFP-407-G)；雙碳比透析液 RFP-401 (RFP-401-G)；雙碳比透析液 RFP-404 (RFP-404-G)；雙碳比透析液 RFP-456 (RFP-456-G)；鋅鐵離子透析液 2K (RFP-457-G)；鋅鐵離子透析液 4K (RFP-458-G)Fresenius Medical Care Renal Therapies Group, LLCK240920HemoCare Bicarbonate Concentrate Set (BCS)Deka Research and DevelopmentK233950pureFLOW 402 (F00012067)；pureFLOW 406 (F00012068)；pureFLOW 401 (F00012069)；pureFLOW 400 (F00012070)Fresenius Medical Care Renal Therapies Group, LLCK233213NxStage PureFlow 解決方案Nxstage Medical, Inc.

官方來源

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