Product code FKO— Gastroenterology, Urology
ACUTE PERITONEAL DIALYSIS CATHETERS
- Classification name
- Catheter, Peritoneal Dialysis, Single Use
- Device class
- Class 2
- Regulation
- 21 CFR 876.5630
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 16
- First cleared
- Most recent
Market context for product code FKO
FDA has cleared devices under product code FKO between 1976 and 1998, filed by 12 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 1998
- 1991
- 1990
- 1987
- 1986
- 1985
- 1981
- 1980
- 1976
Top applicants under product code FKO
Adverse events under product code FKO
product code FKO- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code FKO
- K964514 — CORPAK MEDSYSTEMS CRUZ CATHETER FOR PERITONEAL DIALYSIS
- K974570 — PERITONEAL DIALYSIS CATHETER CONNECTOR
- K910787 — TITANIUM CONNECTOR (2 PART)
- K885037 — AMUKIN 50% - AIRSPRAY(R)
- K874650 — PERITONEAL DIALYSIS KIT (ACUTE AND CHRONIC FORM)
- K872221 — DIALY-NATE SET & DIALY-NATE CATHETER
- K871730 — MODIFIED USE OF PULL-APART INTRODUCER SET
- K870472 — ACUTE PERITONEAL DIALYSIS KIT
- K860155 — PERITONEAL LAVAGE CATH PLC-8,SET PLS-8, KIT PLK-8
- K854966 — ACUTE PERITONEAL DIALYSIS CATHETERS
- K845041 — CAPD STAGED CONNECTOR
- K813336 — LAZARUS-NELSON PERITONEAL LAVAGE TRAY
- K812717 — NON-STERILE SHADOW-STRIPE CATHETER
- K811266 — QUINTON CATHETER FINGER GRIP
- K802954 — DRESSING CHANGE TRAY-MEDIUM
- K760544 — CATHETER, PERITONEAL DIALYSIS
Data sourced from openFDA. This site is unofficial and independent of the FDA.