510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K822732Substantially Equivalent

Lineguard Catheter Shield Model 100

Ray-Marshall Laboratory, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K822732 is the FDA 510(k) clearance record for LINEGUARD CATHETER SHIELD MODEL 100, a class I device, cleared for Ray-Marshall Laboratory on under FDA product code KMK (Device, Intravascular Catheter Securement). FDA records list one 510(k) clearance for Ray-Marshall Laboratory. As of , FDA records show no recalls naming K822732.

Clearance record

Decision date
Received
(16 days to decision)
Product code
KMK Device, Intravascular Catheter Securement
Regulation
21 CFR 880.5210
Device class
Class I
Review panel
General Hospital
Applicant
Ray-Marshall Laboratory 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KMK

Trailing 12 months

FDA records hold no clearances under product code KMK in the trailing twelve months.

FDA records show no clearances under product code KMK in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KMK, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260