← Back to catalogue

Dextrolyte II, Peritoneal Dialysis Cycler Set

FDA 510(k)

Class II (US FDA 510(k))

510(k) K900012

by National Medical Care, Medical Products Div., Inc.

Identifiers

510(k) Number
K900012 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)

This device is a set for peritoneal dialysis administration, classified as disposable. It is designed for use in peritoneal dialysis procedures.

The device is supplied as a disposable set and has received FDA 510(k) clearance under K900012. It is classified as Class II with special controls and is intended for use in clinical settings where peritoneal dialysis is performed.

Frequently asked questions

What is the DEXTROLYTE II Peritoneal Dialysis Cycler Set used for?

The DEXTROLYTE II is a disposable set designed for peritoneal dialysis administration, intended for use in clinical settings where peritoneal dialysis procedures are performed, as specified in its FDA 510(k) clearance documentation.

How is the DEXTROLYTE II supplied and is it reusable?

The DEXTROLYTE II is supplied as a disposable set, meaning it is intended for single-use only and should not be reused, reprocessed, or resterilized after initial use in a peritoneal dialysis procedure.

What regulatory clearance does the DEXTROLYTE II have?

The DEXTROLYTE II has received FDA 510(k) clearance under submission number K900012, classified as a Class II device with special controls, and was determined to be substantially equivalent to a predicate device.

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 Cycler Set, K895990 FDA 510(k) - DEXTROLYTE II PERITONEAL DIALYSIS CYCLE..., K900008 - DEXTROLYTE II | FDA 510 (k), DEXTROLYTE II, PERITONEAL DIALYSIS CYCLER SET - (8) 510 (k) K896599 ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
National Medical Care, Medical Products Div., Inc.

Sources (1)

  • FDA 510(k) K900012 24 fields · synced Sep 24, 2026