Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 set

Q: What is the product code of K212216?

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) K212216 · Baxter Healthcare Corporation

Substantially Equivalent

510(k) numberK212216

Submission

Device name: Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 set
Applicant: Baxter Healthcare Corporation
Deerfield Lake, IL, US
Received: July 16, 2021
Decision date: April 1, 2022
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
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K251640	SIGMA Spectrum Infusion Pump with Master Drug LibraryFRN · Traditional	07/28/2025SE
K251636	Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)FRN · Traditional	07/28/2025SE
K243529	Solution Administration SetsFPA · Traditional	03/14/2025SE
K242339	Intravascular Extension Sets and AccessoriesFPA · Traditional	02/28/2025SE
K242390	Novum IQ Syringe Pump (40800BAXUS)FRN · Special	09/05/2024SE
K241564	Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISMQV · Traditional	08/02/2024SE
K230665	Dose IQ Safety SoftwarePHC · Traditional	03/29/2024SE
K211122	Novum IQ Large Volume PumpFRN · Traditional	03/29/2024SE
K231849	MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A; MiniCap Extended…KDJ · Traditional	03/12/2024SE

Questions and answers

When was Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 set cleared by the FDA?

Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 set (K212216) received a 510(k) decision of Substantially Equivalent on April 1, 2022, 259 days after the submission was received.

What is the product code of K212216?

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.