2008T HD SYS. CDX BLUESTAR (191124) +3 more models

FDA 510(k)

Class II (US FDA 510(k))

510(k) K243237

by Fresenius Medical Care Renal Therapies Group, LLC

Identifiers

510(k) Number: K243237 FDA 510(k)
FDA Product Code: KDI FDA 510(k)
Models / Variants: 2008T HD SYS. CDX BLUESTAR (191124) FDA 510(k)
2008T HD SYS. CDX W/bibag BLUESTAR (191126) FDA 510(k)
2008T HD SYS. W/O CDX BLUESTAR (191128) FDA 510(k)
2008T HD SYS. W/O CDX W/bibag BLUESTAR (191130) FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 876.5860 FDA 510(k)
Regulation Number: 876.5860 FDA 510(k)
Advisory Committee: Gastroenterology, Urology FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

The 2008t Hd Sys Cdx Bluestar is a dialyzer, high permeability with or without sealed dialysate system. It is used for bicarbonate hemodialysis in acute and chronic renal failure. The system is designed to work with hemodialysis machines equipped with the bibag module, such as the 2008t Bluestar Hemodialysis Machine.

The device is supplied in various configurations, including with or without the CDX and bibag options, and is identified by model numbers 191124, 191126, 191128, and 191130. It has been cleared by the FDA with a 510(k) number K243237 and is classified under regulation number 876.5860.

Frequently asked questions

What is the 2008T HD SYS used for?

The 2008T HD SYS is used for bicarbonate hemodialysis in acute and chronic renal failure, providing a high permeability dialysis solution.

Is the 2008T HD SYS supplied with a sealed dialysate system?

The 2008T HD SYS is available with or without a sealed dialysate system, depending on the configuration, including options with or without the CDX and bibag modules.

What are the different models of the 2008T HD SYS?

The 2008T HD SYS is available in several models, including 191124, 191126, 191128, and 191130, each with different configurations and options.

Is the 2008T HD SYS cleared by the FDA?

Yes, the 2008T HD SYS has been cleared by the FDA with a 510(k) number K243237, indicating that it is 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: 2008T HD SYS. CDX BLUESTAR (191124); 2008T HD SYS. CDX W/bibag BLUESTAR ..., Fresenius Medical Care Recalls Some Hemodialysis Machines for Potential ..., 2008T HD SYS. CDX BLUESTAR (191124); 2008T HD SYS… - FDA.report, 2008T HD SYS. CDX BLUESTAR (191124); 2008T HD SYS… - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K243237	Class II	Active

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Manufacturer

Manufacturer: Fresenius Medical Care Renal Therapies Group, LLC

Sources (1)

FDA 510(k) K243237 24 fields · synced Sep 24, 2026