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

Analyzer, Pacemaker Generator Function, Indirect

21 CFR 870.3640 / Cardiovascular
FDA source (opens on fda.gov)

KRE is the FDA product code for Analyzer, Pacemaker Generator Function, Indirect, a class II device type, regulated under 21 CFR 870.3640. As of , FDA records hold 13 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
KRE
Device name
Analyzer, Pacemaker Generator Function, Indirect
Regulation
21 CFR 870.3640
Device class
Class II
Review panel
Cardiovascular
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
13
Ingested recalls
0

Clearances, product code KRE

By decision year
13 clearances under product code KRE with a decision year between 1980 and 2011, 1980 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code KRE by decision year
YearClearances
19803
19811
19832
19871
19901
19921
19931
20031
20081
20111

Applicants with the most clearances

Product code KRE
Applicants holding the most 510(k) clearances under product code KRE
ApplicantClearances
Instromedix, Inc.2
Medtronic, Inc.2
Paceart, Inc.2
Bib, Inc.1
BIOTRONIK AG1
Cygnus, LLC1
Micromedical, Inc.1
Pacesetter Systems1
Powers Medical Systmes1
Siemens Elema AB1

Companies listing this code with FDA

Companies whose registered establishments list this code