Firefly Peritoneal Dialysis Connector Disinfection System

Q: What is the product code of K151620?

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) K151620 · Puracath Medical, Inc.

Substantially Equivalent

510(k) numberK151620

Submission

Device name: Firefly Peritoneal Dialysis Connector Disinfection System
Applicant: Puracath Medical, Inc.
San Francisco, CA, US
Received: June 16, 2015
Decision date: January 20, 2016
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
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

More from Fresensius Medical Care North America

510(k)	Device	Decision
K251375	PuraCath Firefly Needleless Connector IT (9005)FPA · Traditional	02/12/2026SE
K203796	Firefly Needleless ConnectorFPA · Traditional	07/30/2021SE

Questions and answers

When was Firefly Peritoneal Dialysis Connector Disinfection System cleared by the FDA?

Firefly Peritoneal Dialysis Connector Disinfection System (K151620) received a 510(k) decision of Substantially Equivalent on January 20, 2016, 218 days after the submission was received.

What is the product code of K151620?

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