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

Manometer, Blood-Pressure, Venous

21 CFR 870.1140 / Cardiovascular
FDA source (opens on fda.gov)

KRK is the FDA product code for Manometer, Blood-Pressure, Venous, a class II device type, regulated under 21 CFR 870.1140. As of , FDA records hold 9 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
KRK
Device name
Manometer, Blood-Pressure, Venous
Regulation
21 CFR 870.1140
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
9
Ingested recalls
2

Clearances, product code KRK

By decision year
9 clearances under product code KRK with a decision year between 1979 and 1995, 1979 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code KRK by decision year
YearClearances
19791
19811
19821
19831
19861
19881
19891
19901
19951

Applicants with the most clearances

Product code KRK
Applicants holding the most 510(k) clearances under product code KRK
ApplicantClearances
Burron Medical Products, Inc.2
Aloka Co., Ltd.1
Deco Medical, Inc.1
Ethitek Pharmaceuticals Co.1
Exco, Inc.1
Medex, Inc.1
Schneider-Shilley (USA)1
Shiley, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code