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

Device, Beam Limiting, X-Ray, Diagnostic

21 CFR 892.1610 / Radiology
FDA source (opens on fda.gov)

KPW is the FDA product code for Device, Beam Limiting, X-Ray, Diagnostic, a class II device type, regulated under 21 CFR 892.1610. As of , FDA records hold 16 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
KPW
Device name
Device, Beam Limiting, X-Ray, Diagnostic
Regulation
21 CFR 892.1610
Device class
Class II
Review panel
Radiology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
16
Ingested recalls
0

Clearances, product code KPW

By decision year
16 clearances under product code KPW with a decision year between 1977 and 2010, 1982 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code KPW by decision year
YearClearances
19771
19781
19791
19811
19823
19902
19912
19952
20031
20061
20101

Applicants with the most clearances

Product code KPW
Applicants holding the most 510(k) clearances under product code KPW
ApplicantClearances
Tecnomed, Inc.2
Arrow X-Ray Corp.1
Dial-X Instruments, Inc.1
Eureka X-Ray Tube Corp.1
L. Keroack Co.1
Litton Medical Systems1
Lumos, Inc.1
Precise Optics1
Ralco S.r.l.1
Ralco S.r.l.1

Companies listing this code with FDA

Companies whose registered establishments list this code