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

Calibrator, Dose, Radionuclide

21 CFR 892.1360 / Radiology
FDA source (opens on fda.gov)

KPT is the FDA product code for Calibrator, Dose, Radionuclide, a class II device type, regulated under 21 CFR 892.1360. As of , FDA records hold 32 510(k) clearances under this code, the most recent dated , and 4 recalls.

Classification record

Product code
KPT
Device name
Calibrator, Dose, Radionuclide
Regulation
21 CFR 892.1360
Device class
Class II
Review panel
Radiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
32
Ingested recalls
4

Clearances, product code KPT

By decision year
32 clearances under product code KPT with a decision year between 1977 and 2019, 1984 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code KPT by decision year
YearClearances
19771
19812
19821
19845
19852
19881
19891
19911
19931
19942
20001
20012
20023
20031
20041
20071
20091
20101
20142
20171
20191

Applicants with the most clearances

Product code KPT
Applicants holding the most 510(k) clearances under product code KPT
ApplicantClearances
Mirion Technologies (Capintec), Inc.6
Capintec Instruments, Inc.3
Radcal3
Clinicomp, Inc.2
Standard Imaging Inc.2
Sun Nuclear Corporation2
Victoreen, Inc.2
Atomic Products Corp.1
Sport Medical Technology Inc1
Comecer Netherlands B.V.1

Companies listing this code with FDA

Companies whose registered establishments list this code