510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K221965Substantially Equivalent

FemDx FalloView

Femdx Medsystems, Inc., Santa Clara CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K221965 is the FDA 510(k) clearance record for FemDx FalloView, a class II device, cleared for Femdx Medsystems, Inc. on under FDA product code MKO (Falloposcope). FDA records list one 510(k) clearance for Femdx Medsystems, Inc. As of , FDA records show no recalls naming K221965.

Clearance record

Decision date
Received
(255 days to decision)
Product code
MKO Falloposcope
Regulation
21 CFR 884.1690
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Femdx Medsystems, Inc. 2336 Walsh Ave., Santa Clara CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MKO

Trailing 12 months

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

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