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

Cable, Electrode

21 CFR 890.1175 / Physical Medicine
FDA source (opens on fda.gov)

IKD is the FDA product code for Cable, Electrode, a class II device type, regulated under 21 CFR 890.1175. As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and 11 recalls.

Classification record

Product code
IKD
Device name
Cable, Electrode
Regulation
21 CFR 890.1175
Device class
Class II
Review panel
Physical Medicine
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
6
Ingested recalls
11

Clearances, product code IKD

By decision year
6 clearances under product code IKD with a decision year between 1980 and 2007, 1980 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code IKD by decision year
YearClearances
19801
19841
19871
19931
19991
20071

Applicants with the most clearances

Product code IKD
Applicants holding the most 510(k) clearances under product code IKD
ApplicantClearances
Chemfet Corp.1
Oscor Inc.1
Physiometrix, Inc.1
Quinton, Inc.1
R2 Corp.1
Therapy Equipment, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 185 companies shown, in name order