510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K812080Substantially Equivalent

Aegis i.v. Strips

Warner-Lambert Co., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K812080 is the FDA 510(k) clearance record for AEGIS I.V. STRIPS, a class I device, cleared for Warner-Lambert Co. on under FDA product code KMK (Device, Intravascular Catheter Securement). FDA records list 50 510(k) clearances for Warner-Lambert Co., from to . As of , FDA records show no recalls naming K812080.

Clearance record

Decision date
Received
(12 days to decision)
Product code
KMK Device, Intravascular Catheter Securement
Regulation
21 CFR 880.5210
Device class
Class I
Review panel
General Hospital
Applicant
Warner-Lambert Co. 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