MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A; MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short - Code 5C4483

Q: What is the product code of K231849?

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) K231849 · Baxter Healthcare

Substantially Equivalent

510(k) numberK231849

Submission

Device name: MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A; MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short - Code 5C4483
Applicant: Baxter Healthcare
Round Lake, IL, US
Received: June 23, 2023
Decision date: March 12, 2024
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
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
K152129	FlexiCap Disconnect Cap with Povidone-Iodine Solution, MiniCap with Povidone-Iodine…KDJ · Traditional	Baxter Healthcare Corporation	10/29/2015SE
K124024	Apd Luer-Lock AdapterKDJ · Traditional	Fresensius Medical Care North America	09/19/2013SE

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Questions and answers

When was MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A; MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short - Code 5C4483 cleared by the FDA?

MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A; MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short - Code 5C4483 (K231849) received a 510(k) decision of Substantially Equivalent on March 12, 2024, 263 days after the submission was received.

What is the product code of K231849?

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