510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K921518Substantially Equivalent

Lifetek Iui Catheter

Lifetek Medical, Inc., Deforest WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K921518 is the FDA 510(k) clearance record for LIFETEK IUI CATHETER, a class II device, cleared for Lifetek Medical, Inc. on under FDA product code MFD (Cannula, Intrauterine Insemination). FDA records list 2 510(k) clearances for Lifetek Medical, Inc., from to . As of , FDA records show no recalls naming K921518.

Clearance record

Decision date
Received
(770 days to decision)
Product code
MFD Cannula, Intrauterine Insemination
Regulation
21 CFR 884.5250
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Lifetek Medical, Inc. 100 W. N. St., Deforest WI
510(k) summary
Statement
Third party review
No

Clearances, product code MFD

Trailing 12 months

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

FDA records show no clearances under product code MFD in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MFD, 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