FKO

16 FDA 510(k) clearances · Product code

37 daysmedian time to decision

605 days90th percentile

16clearances measured

FDA profile

Official device name: Catheter, Peritoneal Dialysis, Single Use
Device class: Class II (moderate risk)
Regulation: 21 CFR 876.5630
Medical specialty: Gastroenterology, Urology
Flags: Life-sustaining
Adverse events (MAUDE): 1993: 2 · 1994: 3 · 2001: 1 · 2003: 12 · 2004: 2 · 2017: 11
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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Record	Firm	Date
CORPAK MEDSYSTEMS CRUZ CATHETER FOR PERITONEAL DIALYSIS (K964514)	Corpak, Inc.	1998-06-26
PERITONEAL DIALYSIS CATHETER CONNECTOR (K974570)	Medigroup, Inc.	1998-02-27
TITANIUM CONNECTOR (2 PART) (K910787)	Accurate Surgical Instruments Co.	1991-08-15
AMUKIN 50% - AIRSPRAY(R) (K885037)	Bernard J. Cooney, P.A.	1990-10-19
PERITONEAL DIALYSIS KIT (ACUTE AND CHRONIC FORM) (K874650)	Quinton, Inc.	1987-12-09
DIALY-NATE SET & DIALY-NATE CATHETER (K872221)	Gesco Intl., Inc.	1987-10-13
MODIFIED USE OF PULL-APART INTRODUCER SET (K871730)	Quinton, Inc.	1987-05-18
ACUTE PERITONEAL DIALYSIS KIT (K870472)	Quinton, Inc.	1987-02-25
PERITONEAL LAVAGE CATH PLC-8,SET PLS-8, KIT PLK-8 (K860155)	Medical Components, Inc.	1986-02-14
ACUTE PERITONEAL DIALYSIS CATHETERS (K854966)	Thermedics, Inc.	1986-01-09
CAPD STAGED CONNECTOR (K845041)	Abbott Laboratories	1985-02-21
LAZARUS-NELSON PERITONEAL LAVAGE TRAY (K813336)	American Pharmaseal Div. Ahsc	1981-12-18
NON-STERILE SHADOW-STRIPE CATHETER (K812717)	Quinton, Inc.	1981-10-19
QUINTON CATHETER FINGER GRIP (K811266)	Quinton, Inc.	1981-06-18
DRESSING CHANGE TRAY-MEDIUM (K802954)	Associated Medical Products Co.	1980-12-17
CATHETER, PERITONEAL DIALYSIS (K760544)	Travenol Laboratories, S.A.	1976-10-20

Track FKO automatically

Every clearance here is in the API, with alerts when new ones post.