FlexiCap Disconnect Cap with Povidone-Iodine Solution, MiniCap with Povidone-Iodine Solution

Q: What is the product code of K152129?

The FDA product code is KDJ – Set, Administration, For Peritoneal Dialysis, Disposable, a Class II (moderate risk) device regulated under 21 CFR 876.5630.

FDA 510(k) K152129 · Baxter Healthcare Corporation

Substantially Equivalent

510(k) numberK152129

Submission

Device name: FlexiCap Disconnect Cap with Povidone-Iodine Solution, MiniCap with Povidone-Iodine Solution
Applicant: Baxter Healthcare Corporation
Round Lake, IL, US
Received: July 31, 2015
Decision date: October 29, 2015
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: KDJ – Set, Administration, For Peritoneal Dialysis, Disposable
Device class: Class II (moderate risk)
Regulation: 21 CFR 876.5630
Specialty: Gastroenterology, Urology
Life-sustaining: Yes

Other 510(k)s with product code KDJ

510(k)	Device	Applicant	Decision
K250404	staysafe® catheter extension set with Safe- Lock, 12 inch; staysafe® catheter…KDJ · Traditional	Fresenius Medical Care Renal Therapies Group, LLC	04/03/2025SE
K231849	MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A; MiniCap Extended…KDJ · Traditional	Baxter Healthcare	03/12/2024SE
K214016	15L Cycler Drainage BagKDJ · Traditional	Baxter Healthcare Corporation	03/18/2022SE
K192705	MiniCap Extended Life PD Transfer SetsKDJ · Special	Baxter Healthcare	10/25/2019SE
K173593	staysafe catheter extension set with Safe-Lock, 12 inch, staysafe catheter extension…KDJ · Traditional	Fresenius Medical Care Renal Therapies Group, LLC	05/21/2018SE
K173651	Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain SetKDJ · Traditional	Fresenius Medical Care Renal Therapies Group, LLC	02/14/2018SE
K173363	Cycler Drain Bag SetKDJ · Traditional	Fresenius Medical Care Renal Therapies Group, LLC	01/24/2018SE
K151620	Firefly Peritoneal Dialysis Connector Disinfection SystemKDJ · Traditional	Puracath Medical, Inc.	01/20/2016SE
K152675	Extended Life Capd Transfer Set, Peritoneal Dialysis Titanium Catheter Adapter and…KDJ · Traditional	Baxter Healthcare	10/29/2015SE
K124024	Apd Luer-Lock AdapterKDJ · Traditional	Fresensius Medical Care North America	09/19/2013SE

More from Fresensius Medical Care North America

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 FlexiCap Disconnect Cap with Povidone-Iodine Solution, MiniCap with Povidone-Iodine Solution cleared by the FDA?

FlexiCap Disconnect Cap with Povidone-Iodine Solution, MiniCap with Povidone-Iodine Solution (K152129) received a 510(k) decision of Substantially Equivalent on October 29, 2015, 90 days after the submission was received.

What is the product code of K152129?

The FDA product code is KDJ – Set, Administration, For Peritoneal Dialysis, Disposable, a Class II (moderate risk) device regulated under 21 CFR 876.5630.