DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF 06); SH 14 Hemoconcentrator (SH 14)

Q: What is the product code of K243264?

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) K243264 · Sorin Group Italia S.R.L.

Substantially Equivalent

510(k) numberK243264

Submission

Device name: DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF 06); SH 14 Hemoconcentrator (SH 14)
Applicant: Sorin Group Italia S.R.L.
Mirandola ( Modena), IT
Received: October 15, 2024
Decision date: April 25, 2025
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 DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF 06); SH 14 Hemoconcentrator (SH 14) cleared by the FDA?

DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF 06); SH 14 Hemoconcentrator (SH 14) (K243264) received a 510(k) decision of Substantially Equivalent on April 25, 2025, 192 days after the submission was received.

What is the product code of K243264?

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.