DeviceClearance

Product code KMK— General Hospital

A P HARNESS

Classification name
Device, Intravascular Catheter Securement
Device class
Class 1
Regulation
21 CFR 880.5210
Advisory panel
General Hospital
Total cleared
64
First cleared
Most recent

Market context for product code KMK

FDA has cleared 64 devices under product code KMK between 1977 and 2019, filed by 54 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

last 15 years

Top applicants under product code KMK

Adverse events under product code KMK

product code KMK
Malfunction
461
Other
1
Total
462

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code KMK

Data sourced from openFDA. This site is unofficial and independent of the FDA.