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

System Accessories, Extracorporeal

21 CFR 876.5820 / Gastroenterology, Urology
FDA source (opens on fda.gov)

KXM is the FDA product code for System Accessories, Extracorporeal, a class II device type, regulated under 21 CFR 876.5820. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
KXM
Device name
System Accessories, Extracorporeal
Regulation
21 CFR 876.5820
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
4
Ingested recalls
0

Clearances, product code KXM

By decision year
4 clearances under product code KXM with a decision year between 1983 and 1995, 1983 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code KXM by decision year
YearClearances
19831
19851
19861
19951

Applicants with the most clearances

Product code KXM
Applicants holding the most 510(k) clearances under product code KXM
ApplicantClearances
Baxter Healthcare Corporation1
Colorado Medical, Inc.1
Cp Medical1
Parker Hannifin Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code