510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K190522Substantially Equivalent

Allwin Intra Uterine Insemination Catheters (INSEMINA and INSEMINA Open Tip Intra Uterine Insemination Catheter, CURVED and CURVED Open Tip Intra Uterine Insemination Catheter, TRACKABLE and TRACKABLE Open Tip Intra Uterine Insemination Catheter, FLEXI and FLEXI Open Tip Intra Uterine Insemination Catheter, STUMPY Intra Uterine Insemination Catheter)

Allwin Medical Devices, Inc., Anaheim CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K190522 is the FDA 510(k) clearance record for Allwin Intra Uterine Insemination Catheters (INSEMINA and INSEMINA Open Tip Intra Uterine Insemination Catheter, CURVED and CURVED Open Tip Intra Uterine Insemination Catheter, TRACKABLE and TRACKABLE Open Tip Intra Uterine Insemination Catheter, FLEXI and FLEXI Open Tip Intra Uterine Insemination Catheter, STUMPY Intra Uterine Insemination Catheter), a class II device, cleared for Allwin Medical Devices, Inc. on under FDA product code MQF (Catheter, Assisted Reproduction). FDA records list 7 510(k) clearances for Allwin Medical Devices, Inc., from to . As of , FDA records show no recalls naming K190522.

Clearance record

Decision date
Received
(255 days to decision)
Product code
MQF Catheter, Assisted Reproduction
Regulation
21 CFR 884.6110
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Allwin Medical Devices, Inc. 3305 E. Mira Loma Ave., Suite 176, Anaheim CA
510(k) summary
Statement
Third party review
No

Clearances, product code MQF

Trailing 12 months
1 clearance under product code MQF in the twelve months to October 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MQF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260