510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K222932Substantially Equivalent

INVOcell Intravaginal Culture System

Invo Bioscience, Sarasota FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K222932 is the FDA 510(k) clearance record for INVOcell Intravaginal Culture System, a class II device, cleared for Invo Bioscience on under FDA product code OYO (Culture, Intravaginal, Assisted Reproduction). FDA's definition for product code OYO reads: "Intravaginal culture of human gametes and embryos. To hold and maintain gametes and developing embryos over the duration of the intravaginal culture period". FDA records list 2 510(k) clearances for Invo Bioscience, from to . As of , FDA records show no recalls naming K222932.

Clearance record

Decision date
Received
(269 days to decision)
Product code
OYO Culture, Intravaginal, Assisted Reproduction
Regulation
21 CFR 884.6165
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Invo Bioscience 5582 Broadcast Ct., Sarasota FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OYO

Trailing 12 months

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

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