510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K231203Substantially Equivalent

Mosie Baby Kit

Mosie Baby, Austin TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K231203 is the FDA 510(k) clearance record for Mosie Baby Kit, a class II device, cleared for Mosie Baby on under FDA product code QYZ (At Home Intravaginal Insemination System). FDA's definition for product code QYZ reads: "To deliver semen to the vaginal canal for insemination". FDA records list one 510(k) clearance for Mosie Baby. As of , FDA records show no recalls naming K231203.

Clearance record

Decision date
Received
(216 days to decision)
Product code
QYZ At Home Intravaginal Insemination System
Regulation
21 CFR 884.6110
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Mosie Baby P.O. Box 140753, Austin TX
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QYZ

Trailing 12 months

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

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