Product Code: FKO FDA class 2 21 CFR 876.5630

Catheter, Peritoneal Dialysis, Single Use

Gastroenterology, Urology

The Single-Use Peritoneal Dialysis Catheter is a disposable catheter intended for single-session peritoneal dialysis, providing temporary access to the peritoneal cavity for infusion and drainage of dialysate. It is classified as FDA Class 2 (moderate risk) and requires 510(k) premarket notification. The product code is FKO, regulated under 21 CFR 876.5630 in the Gastroenterology and Urology specialty. This device is designated as life sustaining or life supporting.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: FKO
Device Class: FDA class 2
Regulation Number: 876.5630
Medical Specialty: Gastroenterology, Urology
Review Panel: GU
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✓

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 16 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K964514	CORPAK MEDSYSTEMS CRUZ CATHETER FOR PERITONEAL DIALYSIS	Jun 26, 1998	Substantially Equivalent	Corpak, Inc.
K974570	PERITONEAL DIALYSIS CATHETER CONNECTOR	Feb 27, 1998	Substantially Equivalent	Medigroup, Inc.
K910787	TITANIUM CONNECTOR (2 PART)	Aug 15, 1991	Substantially Equivalent	Accurate Surgical Instruments Co.
K885037	AMUKIN 50% - AIRSPRAY(R)	Oct 19, 1990	Substantially Equivalent	Bernard J. Cooney, P.A.
K874650	PERITONEAL DIALYSIS KIT (ACUTE AND CHRONIC FORM)	Dec 09, 1987	Substantially Equivalent	Quinton, Inc.
K872221	DIALY-NATE SET & DIALY-NATE CATHETER	Oct 13, 1987	Substantially Equivalent	Gesco Intl., Inc.
K871730	MODIFIED USE OF PULL-APART INTRODUCER SET	May 18, 1987	Substantially Equivalent	Quinton, Inc.
K870472	ACUTE PERITONEAL DIALYSIS KIT	Feb 25, 1987	Substantially Equivalent	Quinton, Inc.
K860155	PERITONEAL LAVAGE CATH PLC-8,SET PLS-8, KIT PLK-8	Feb 14, 1986	Unknown	Medical Components, Inc.
K854966	ACUTE PERITONEAL DIALYSIS CATHETERS	Jan 09, 1986	Substantially Equivalent	Thermedics, Inc.
K845041	CAPD STAGED CONNECTOR	Feb 21, 1985	Substantially Equivalent	Abbott Laboratories
K813336	LAZARUS-NELSON PERITONEAL LAVAGE TRAY	Dec 18, 1981	Substantially Equivalent	American Pharmaseal Div. Ahsc
K812717	NON-STERILE SHADOW-STRIPE CATHETER	Oct 19, 1981	Substantially Equivalent	Quinton, Inc.
K811266	QUINTON CATHETER FINGER GRIP	Jun 18, 1981	Substantially Equivalent	Quinton, Inc.
K802954	DRESSING CHANGE TRAY-MEDIUM	Dec 17, 1980	Substantially Equivalent	Associated Medical Products Co.
K760544	CATHETER, PERITONEAL DIALYSIS	Oct 20, 1976	Substantially Equivalent	Travenol Laboratories, S.A.