Gambro Polyflux 6L, Gambro Polyflux 8L, Gambro Polyflux 10L, Model 6L, 8L, 10L

Q: What is the product code of K010985?

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) K010985 · Gambro Renal Products

Substantially Equivalent

510(k) numberK010985

Submission

Device name: Gambro Polyflux 6L, Gambro Polyflux 8L, Gambro Polyflux 10L, Model 6L, 8L, 10L
Applicant: Gambro Renal Products
Lakewood, CO, US
Received: April 2, 2001
Decision date: October 10, 2001
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

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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

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Questions and answers

When was Gambro Polyflux 6L, Gambro Polyflux 8L, Gambro Polyflux 10L, Model 6L, 8L, 10L cleared by the FDA?

Gambro Polyflux 6L, Gambro Polyflux 8L, Gambro Polyflux 10L, Model 6L, 8L, 10L (K010985) received a 510(k) decision of Substantially Equivalent on October 10, 2001, 191 days after the submission was received.

What is the product code of K010985?

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.