Dextrolyte II, Peritoneal Dialysis No. 48-1015-6
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K900243 FDA 510(k)
- FDA Product Code
- KDJ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.5630 FDA 510(k)
- Regulation Number
- 876.5630 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Dextrolyte II, Peritoneal Dialysis No. 48-1015-6 is a disposable administration set for peritoneal dialysis. It is part of a peritoneal dialysis system used as an artificial kidney to treat patients with renal failure or toxemic conditions by delivering dialysate into the peritoneal cavity.
The device is supplied as a single‑use, sterile set and is classified as a Class II device (product code KDJ) with special controls. It received FDA 510(k) clearance (decision date 1990‑03‑22, decision description Substantially Equivalent) and is intended for use in peritoneal dialysis procedures.
Frequently asked questions
What is the Dextrolyte II Peritoneal Dialysis Administration Set used for?
The Dextrolyte II Peritoneal Dialysis Administration Set is a disposable device used in peritoneal dialysis procedures to deliver dialysate into the peritoneal cavity, serving as an artificial kidney to treat patients with renal failure or toxemic conditions.
Is the Dextrolyte II Peritoneal Dialysis Administration Set single-use or reusable?
The Dextrolyte II Peritoneal Dialysis Administration Set is supplied as a single-use, sterile set, designed for one-time use only to ensure patient safety and prevent cross-contamination.
What is the regulatory classification of the Dextrolyte II Peritoneal Dialysis Administration Set?
The device is classified as a Class II device with special controls (product code KDJ) and received FDA 510(k) clearance on March 22, 1990, with the decision description of 'Substantially Equivalent'.
How is the Dextrolyte II Peritoneal Dialysis Administration Set supplied?
The device is supplied as a complete, sterile, disposable administration set ready for use in peritoneal dialysis procedures, with all components necessary for dialysate delivery to the peritoneal cavity.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Dextrolyte Ii, Peritoneal Dialysis No. 48-1015-6, K900226 - DEXTROLYTE II | FDA 510 (k), K896600 - DEXTROLYTE II | FDA 510 (k)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K900243 | Class II | Active |
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Manufacturer
- Manufacturer
- National Medical Care, Medical Products Div., Inc.
Sources (1)
- FDA 510(k) K900243 24 fields · synced Sep 24, 2026