510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K180073Substantially Equivalent

Vitavitro Vitrification Kit, Vitavitro Warming Kit, and Vitavitro Straw Set

Shenzhen Vitavitro Bio-Tech Co., Ltd., Shenzhen, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K180073 is the FDA 510(k) clearance record for Vitavitro Vitrification Kit, Vitavitro Warming Kit, and Vitavitro Straw Set, a class II device, cleared for Shenzhen Vitavitro Bio-Tech Co., Ltd. on under FDA product code MQL (Media, Reproductive). FDA records list one 510(k) clearance for Shenzhen Vitavitro Bio-Tech Co., Ltd. As of , FDA records show no recalls naming K180073.

Clearance record

Decision date
Received
(232 days to decision)
Product code
MQL Media, Reproductive
Regulation
21 CFR 884.6180
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Shenzhen Vitavitro Bio-Tech Co., Ltd. R601, Bldg. B, Hai Ke Xing Tech Park, Baoshan Rd. #16,, Shenzhen, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MQL

Trailing 12 months
3 clearances under product code MQL 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 MQL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20260
April 20261
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260