# K222932: INVOcell Intravaginal Culture System

- Pathway: 510(k) (Traditional)
- Applicant: Invo Bioscience
- Decided: Jun 22, 2023 after 269 days
- Product code: OYO (Culture, Intravaginal, Assisted Reproduction)
- Device class: 2
- Regulation: 21 CFR 884.6165
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN150008 (2015). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN150008: INVOcell, Invo Bioscience (2015) Summary page 4.

## Indications for use
The INVOcell Intravaginal Culture System consists of the following components: The INVOcell Culture Device is indicated for use in preparing, holding, and transferring human gametes or embryos during In Vitro Fertilization/Intravaginal Culture (IVF/IVC) and Intra-Cytoplasmic Sperm Injection Fertilization/Intravaginal Culture (ICSI/IVC) procedures. The INVOcell Culture Device is indicated for use with the INVOcell Retention Device. The INVOcell Culture Device is not indicated for incubation periods exceeding 120h. The INVOcell Retention Device is indicated for use with the INVOcell Culture Device to aid in retention of the INVOcell Culture Device in the vaginal cavity during the incubation period. The INVOcell Retention Device is not indicated for use exceeding 120h.

Source page: https://510kreport.com/device/K222932
Methodology: https://510kreport.com/methodology