510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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FKXClass II

System, Peritoneal, Automatic Delivery

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

FKX is the FDA product code for System, Peritoneal, Automatic Delivery, a class II device type, regulated under 21 CFR 876.5630. As of , FDA records hold 83 510(k) clearances under this code, the most recent dated , and 51 recalls.

Classification record

Product code
FKX
Device name
System, Peritoneal, Automatic Delivery
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
83
Ingested recalls
51

Clearances, product code FKX

By decision year
83 clearances under product code FKX with a decision year between 1977 and 2025, 1983 the highest year at 19.
Show the numbers
510(k) clearances under FDA product code FKX by decision year
YearClearances
19772
19791
19813
198214
198319
19845
19854
19873
19892
19904
19922
19943
20001
20012
20051
20061
20112
20132
20141
20151
20171
20182
20201
20224
20252

Applicants with the most clearances

Product code FKX
Applicants holding the most 510(k) clearances under product code FKX
ApplicantClearances
American Medical Products LLC11
Fresenius Medical Care Renal Therapies Group, LLC8
Travenol Laboratories, S.A.8
Baxter Healthcare Corporation7
Abbott Medical6
Medigroup5
Medionics International, Inc.5
Quinton, Inc.4
Deka Research & Development Corp.3
Delmed, Inc.3

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 31 companies shown, in name order