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

Device, Iontophoresis, Specific Uses

21 CFR 890.5525 / Physical Medicine
FDA source (opens on fda.gov)

KTB is the FDA product code for Device, Iontophoresis, Specific Uses, a class II device type, regulated under 21 CFR 890.5525. As of , FDA records hold 16 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
KTB
Device name
Device, Iontophoresis, Specific Uses
Regulation
21 CFR 890.5525
Device class
Class II
Review panel
Physical Medicine
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
16
Ingested recalls
0

Clearances, product code KTB

By decision year
16 clearances under product code KTB with a decision year between 1978 and 2018, 2003 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code KTB by decision year
YearClearances
19781
19791
19831
19841
19851
19901
19961
19981
19991
20002
20011
20033
20181

Applicants with the most clearances

Product code KTB
Applicants holding the most 510(k) clearances under product code KTB
ApplicantClearances
Iomed, Inc.6
ELITechGroup Inc4
Medtronic, Inc.2
Mcg, Inc.1
Mcghan Medical Corp.1
Vyteris, Inc.1
WR Medical Electronics Co.1

Companies listing this code with FDA

Companies whose registered establishments list this code