510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K232579Substantially Equivalent

Twoplus Applicator

Hannah Life Technologies Pte, Ltd., Singapore, SG / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K232579 is the FDA 510(k) clearance record for Twoplus Applicator, a class II device, cleared for Hannah Life Technologies Pte , Ltd. 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 Hannah Life Technologies Pte , Ltd. As of , FDA records show no recalls naming K232579.

Clearance record

Decision date
Received
(118 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
Hannah Life Technologies Pte , Ltd. Morningstar Centre, 12 New Industrial Rd., #04-05a, Singapore, SG
510(k) summary
Statement
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