AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory

Q: What is the product code of K201809?

The FDA product code is KDI – Dialyzer, High Permeability With Or Without Sealed Dialysate System, a Class II (moderate risk) device regulated under 21 CFR 876.5860.

FDA 510(k) K201809 · Baxter Healthcare Corportation

Substantially Equivalent

510(k) numberK201809

Submission

Device name: AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory
Applicant: Baxter Healthcare Corportation
Round Lake, IL, US
Received: July 1, 2020
Decision date: March 10, 2021
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: KDI – Dialyzer, High Permeability With Or Without Sealed Dialysate System
Device class: Class II (moderate risk)
Regulation: 21 CFR 876.5860
Specialty: Gastroenterology, Urology
Life-sustaining: Yes

Other 510(k)s with product code KDI

510(k)	Device	Applicant	Decision
K261267	Careflux H60;Careflux H70;Careflux V500KDI · Traditional	Fresenius Medical Care Renal Therapies Group, LLC	07/24/2026SE
K252377	NxStage System One with NxViewKDI · Traditional	Fresenius Medical Care Renal Therapies Group, LLC	05/15/2026SE
K260533	Elisio-HKDI · Special	Nipro Medical Corporation	03/19/2026SE
K252459	multiFlux 130 (F00013123); multiFlux 160 (F00013124)KDI · Traditional	Fresenius Medical Care Renal Therapies Group, LLC	02/10/2026SE
K253412	Tablo Hemodialysis System (PN-0008000, PN-0006000U)KDI · Traditional	Outset Medical, Inc.	01/26/2026SE
K253518	FX CorAL 40; FX CorAL 50KDI · Special	Fresenius Medical Care Renal Therapies Group, LLC	12/18/2025SE
K243920	Purema H Hemoconcentrator - PediatricKDI · Traditional	Medica USA, Inc.	09/19/2025SE
K250508	AK 98 Dialysis Machine (955607)KDI · Traditional	Vantive US Healthcare, LLC	08/01/2025SE
K243237	2008T HD SYS. CDX BLUESTAR (191124); 2008T HD SYS. CDX W/bibag BLUESTAR (191126); 2008T…KDI · Traditional	Fresenius Medical Care Renal Therapies Group, LLC	06/13/2025SE
K243505	5008X Hemodialysis SystemKDI · Traditional	Fresenius Medical Care Renal Therapies Group, LLC	05/30/2025SE

More from Fresenius Medical Care Renal Therapies Group, LLC

510(k)	Device	Decision
K233441	The Vest APX System (PVAPX1)BYI · Traditional	03/22/2024SE
K193137	EASYGRIP FLO-41 Precision MIS Delivery SystemGCJ · Traditional	01/08/2020SE

Questions and answers

When was AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory cleared by the FDA?

AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory (K201809) received a 510(k) decision of Substantially Equivalent on March 10, 2021, 252 days after the submission was received.

What is the product code of K201809?

The FDA product code is KDI – Dialyzer, High Permeability With Or Without Sealed Dialysate System, a Class II (moderate risk) device regulated under 21 CFR 876.5860.