510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K850579Substantially Equivalent

Cue Fertility Monitor

Zetek, Inc., Chicago IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K850579 is the FDA 510(k) clearance record for CUE FERTILITY MONITOR, a class I device, cleared for Zetek, Inc. on under FDA product code NGE (Test, Luteinizing Hormone (Lh), Over The Counter). FDA records list one 510(k) clearance for Zetek, Inc. As of , FDA records show no recalls naming K850579.

Clearance record

Decision date
Received
(37 days to decision)
Product code
NGE Test, Luteinizing Hormone (Lh), Over The Counter
Regulation
21 CFR 862.1485
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Zetek, Inc. Burditt, Bowles & Radzius, Ltd, Chicago IL
Third party review
No

Clearances, product code NGE

Trailing 12 months

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

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