510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K990223Substantially Equivalent

Modification of Clearplan Easy Fertility Monitor

Unipath, Ltd., Bedford, GB / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K990223 is the FDA 510(k) clearance record for MODIFICATION OF CLEARPLAN EASY FERTILITY MONITOR, a class I device, cleared for Unipath , Ltd. on under FDA product code NGE (Test, Luteinizing Hormone (Lh), Over The Counter). FDA records list 73 510(k) clearances for Unipath , Ltd., from to . As of , FDA records show no recalls naming K990223.

Clearance record

Decision date
Received
(30 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
Unipath , Ltd. Priory Business Park, Bedford, GB
510(k) summary
Statement
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