510(k) Report

FDA applicant

Invo Bioscience

Sarasota, FL2 decisions2015–20230 recalls

FDA records 2 decisions for Invo Bioscience (Sarasota, FL) from 2015 to 2023: 1 510(k) clearance and 1 De Novo grant. All are in product code OYO (Culture, Intravaginal, Assisted Reproduction). Its devices cite 1 predicate, 1 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, obstetrics and gynecology panel, where it files most

How often FDA has decided Invo Bioscience’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2015: 12023: 1
2015high 1 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Invo Bioscience by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Invo Bioscience’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • OYOCulture, Intravaginal, Assisted Reproduction2decisions

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • DEN150008INVOcellInvo Bioscience · 20151cites it

What has FDA decided for it lately?

  • K222932INVOcell Intravaginal Culture SystemInvo Bioscience · 2023
  • DEN150008INVOcellInvo Bioscience · 2015

All 2 as Invo Bioscience →