5M1352 Proport. Dialysis Fluid Deliv.ery

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K761287 ↗

FDA Product Code

FKP

Device Class

Class II

Regulation

21 CFR Part 876.5820

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Burette Set with Air Control Lever

  Class II

  FDA 510(k) K780970 Active Cleared 27 Jul 1978

• Sterile Water & Saline in Plastic Btl.

  Class II

  FDA 510(k) K800753 Active Cleared 24 Apr 1980

• Solution Administration Sets

  Class II

  FDA 510(k) K860272 Active Cleared 18 Mar 1986

• Arteoial Blood Sampling Kit 2D9014

  Class II

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• Blood-Solution Administration Set, Surg.

  Class I

  FDA 510(k) K760483 Active Cleared 3 Sep 1976

• Flo-Gard 8000 Computer Control Infusi

  Class II

  FDA 510(k) K834154 Active Cleared 25 Jan 1984

See all devices from Travenol Laboratories, S.A. →

• What is the 5M1352 Proportional Dialysis Fluid Delivery System used for?

  This device is specifically designed for automated, precise delivery of dialysate during peritoneal dialysis procedures. It ensures controlled fluid administration to facilitate the exchange process, which is critical for maintaining proper fluid balance and therapeutic efficacy in patients undergoing peritoneal dialysis. The system adheres to regulatory standards for fluid management in urological and gastrointestinal applications.

• Is the 5M1352 Proportional Dialysis Fluid Delivery System intended for single-use or reuse?

  The 5M1352 Proportional Dialysis Fluid Delivery System is explicitly designed for single-use only in clinical settings. This ensures patient safety and sterility, as reuse could compromise the device’s integrity and introduce contamination risks. Always follow manufacturer guidelines for proper disposal after a single use.

• How is the device supplied, and what sterility guarantees are provided?

  The 5M1352 Proportional Dialysis Fluid Delivery System is supplied sterile by the manufacturer. Sterility is a critical requirement for medical devices used in direct patient care, particularly in dialysis procedures where infection control is paramount. Always verify the sterility seal and expiration date before use to ensure compliance with sterile medical device protocols.

• What regulatory pathway and classification does this device follow?

  The device received FDA 510(k) clearance (K761287) under the Traditional pathway, with a Substantially Equivalent (SESE) determination. It is classified under FDA Product Code FKP and falls within Class II regulatory classification (Regulation Number 876.5820). This classification indicates moderate regulatory oversight, balancing safety and innovation for devices like this.

• How should the 5M1352 Proportional Dialysis Fluid Delivery System be stored?

  Storage must comply with sterile medical device protocols to maintain the device’s integrity before use. This includes keeping it in its original packaging, away from direct sunlight or extreme temperatures, and ensuring the sterility seal remains unbroken. Improper storage could compromise sterility or functionality, so always follow the manufacturer’s instructions for optimal preservation.