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

Device, Intravascular Catheter Securement

21 CFR 880.5210 / General Hospital
FDA source (opens on fda.gov)

KMK is the FDA product code for Device, Intravascular Catheter Securement, a class I device type, regulated under 21 CFR 880.5210. As of , FDA records hold 64 510(k) clearances under this code, the most recent dated , and 7 recalls.

Classification record

Product code
KMK
Device name
Device, Intravascular Catheter Securement
Regulation
21 CFR 880.5210
Device class
Class I
Review panel
General Hospital
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
64
Ingested recalls
7

Clearances, product code KMK

By decision year
64 clearances under product code KMK with a decision year between 1977 and 2019, 1993 the highest year at 10.
Show the numbers
510(k) clearances under FDA product code KMK by decision year
YearClearances
19771
19781
19791
19802
19812
19825
19832
19845
19852
19863
19873
19892
19904
19916
19924
199310
19947
19951
19961
19991
20191

Applicants with the most clearances

Product code KMK
Applicants holding the most 510(k) clearances under product code KMK
ApplicantClearances
Ansley Medical Products, Inc.3
Op-Co Medical Products, Ltd.3
Consolidated Medical Equipment Company2
Dale Medical Products, Inc.2
K-Lok, Inc.2
Saxnor Corp.2
TNT Moborg Intl. Ltd.2
Vitaphore Corp.2
2-Rn Corp.1
Acme United Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 173 companies shown, in name order