510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
FKOClass II

Catheter, Peritoneal Dialysis, Single Use

21 CFR 876.5630 / Gastroenterology, Urology
FDA source (opens on fda.gov)

FKO is the FDA product code for Catheter, Peritoneal Dialysis, Single Use, a class II device type, regulated under 21 CFR 876.5630. As of , FDA records hold 16 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
FKO
Device name
Catheter, Peritoneal Dialysis, Single Use
Regulation
21 CFR 876.5630
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
No
Life sustaining or supporting
Yes
GMP exempt
No
Third party review eligible
No
Ingested clearances
16
Ingested recalls
0

Clearances, product code FKO

By decision year
16 clearances under product code FKO with a decision year between 1976 and 1998, 1987 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code FKO by decision year
YearClearances
19761
19801
19813
19851
19862
19874
19901
19911
19982

Applicants with the most clearances

Product code FKO
Applicants holding the most 510(k) clearances under product code FKO
ApplicantClearances
Quinton, Inc.5
Abbott Medical1
Accurate Surgical Instruments Co.1
American Pharmaseal Div. Ahsc1
Associated Medical Products Co.1
Bernard J. Cooney, P.A.1
Corpak Co.1
Gesco Intl., Inc.1
Medical Components, Inc.1
Medigroup1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 13 companies shown, in name order