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

Transducer, Miniature Pressure

21 CFR 890.1615 / Physical Medicine
FDA source (opens on fda.gov)

IKE is the FDA product code for Transducer, Miniature Pressure, a class I device type, regulated under 21 CFR 890.1615. As of , FDA records hold 15 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
IKE
Device name
Transducer, Miniature Pressure
Regulation
21 CFR 890.1615
Device class
Class I
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
15
Ingested recalls
0

Clearances, product code IKE

By decision year
15 clearances under product code IKE with a decision year between 1984 and 2006, 1987 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code IKE by decision year
YearClearances
19842
19873
19882
19901
19911
19923
19931
19951
20061

Applicants with the most clearances

Product code IKE
Applicants holding the most 510(k) clearances under product code IKE
ApplicantClearances
Broadwest Corp.2
Advanced Rehabilitative Technology, Inc.1
Atlantis Scientific Corp.1
Bar Med Pty, Ltd.1
Breakthrough, Inc.1
Cleveland Medical Devices, Inc.1
Dynatronics Corp.1
Moss Rehabilation Hospital1
Novel Electronics, Inc.1
Novel GmbH1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 13 companies shown, in name order