510(k) · Cleared
ClearedINVOcell Intravaginal Culture System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Invo Bioscience · OYO Culture, Intravaginal, Assisted Reproduction
Cleared on Jun 22, 2023 as substantially equivalent to DEN150008 (Invo Bioscience, 2015) after a 269-day review. Its family tree reaches back 1 generation to 2015.
- Decided
- Jun 22, 2023
- Review
- 269 days
- Class
- Class II
- Product code
- OYO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN150008 (2015). No later device cites it as a predicate yet.
- Root · 1 generation backDEN150008 INVOcellInvo Bioscience · 2015
- This deviceK222932 INVOcell Intravaginal Culture SystemInvo Bioscience · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN150008 | INVOcell | Invo Bioscience | 2015 | — |
| 0 (this device) | K222932 | INVOcell Intravaginal Culture System | Invo Bioscience | 2023 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OYO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN150008 | INVOcellSummary page 4…de(s): OYO (Culture, Intravaginal, Assisted Reproduction) Regulatory Class: II III. Predicate Device INVOcell Intravaginal Culture System (DEN150008) from INVO Bioscience, Inc. The predicate device has not been subject to a design-related recall. IV. Description of th… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All OYO devicesOYO Culture, Intravaginal, Assisted Reproduction: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · OYO
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · OYO
Too few OYO 510(k)s in any year since 2007 to give a median.
Recalls per year · OYO
No recall names OYO since 2007.
Adverse event reports per year · OYO
1in 2017
MAUDE reports naming product code OYO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (107 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222932 · printed Nov 4, 2026
Cite this page
510(k) Report. “K222932: INVOcell Intravaginal Culture System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K222932
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026