510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
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K053646Substantially Equivalent

Invitro Maturation Media

Sage In-Vitro Fertilization, Inc., Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K053646 is the FDA 510(k) clearance record for INVITRO MATURATION MEDIA, a class II device, cleared for Sage In-Vitro Fertilization, Inc. on under FDA product code MQL (Media, Reproductive). FDA records list 2 510(k) clearances for Sage In-Vitro Fertilization, Inc., from to . As of , FDA records show no recalls naming K053646.

Clearance record

Decision date
Received
(196 days to decision)
Product code
MQL Media, Reproductive
Regulation
21 CFR 884.6180
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Sage In-Vitro Fertilization, Inc. 3722 Ave. Sausalito, Irvine CA
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