Closed Disconnect System

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K900106 ↗

FDA Product Code

KDJ

Device Class

Class II

Regulation

21 CFR Part 876.5630

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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See all devices from Delmed, Inc. →

• What is the Closed Disconnect System designed for?

  The Closed Disconnect System is a disposable medical device specifically designed for peritoneal dialysis procedures. It acts as a sterile barrier between fluid pathways to prevent contamination during fluid exchange, thereby maintaining fluid integrity and minimizing infection risk for patients undergoing dialysis.

• Is this system single-use or reusable?

  This system is intended for single-use only. It is classified as a disposable device, meaning it should not be reused after a single procedure to ensure patient safety and sterility.

• How should the Closed Disconnect System be stored to maintain sterility?

  The system must be stored according to the manufacturer’s guidelines to preserve its sterility. It is designed for use in sterile environments, such as clinical dialysis settings, and should be handled with care to avoid contamination before use.

• What regulatory approval does this device hold?

  The Closed Disconnect System holds FDA 510(k) clearance under the reference number K900106. It is classified under regulatory category II and is authorized as substantially equivalent to a predicate device, adhering to standards outlined in 21 CFR Part 876.5630.

• Are there specific compatibility requirements for this system?

  The system is sized for compatibility with peritoneal dialysis circuits. It is not MRI-safe, so it should not be used in MRI environments. Always ensure proper sizing and compatibility with the dialysis setup to avoid procedural complications.