Not Cleared Direct

DEN150008 - INVOcell (FDA 510(k) Clearance)

Class II Obstetrics & Gynecology device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN150008 · Invo Bioscience · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2015
Decision
252d
Days
Class 2
Risk

DEN150008 is an FDA 510(k) submission (not cleared) for the INVOcell. Classified as Culture, Intravaginal, Assisted Reproduction (product code OYO), Class II - Special Controls.

Submitted by Invo Bioscience (Medford, US). The FDA issued a Not Cleared (DENG) decision on November 2, 2015 after a review of 252 days.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.6165 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. Elevated predicate reliance profile. With 252 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Invo Bioscience devices

Submission Details

510(k) Number DEN150008 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received February 23, 2015
Decision Date November 02, 2015
Days to Decision 252 days
Submission Type Direct
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d slower than avg
Panel avg: 160d · This submission: 252d
Pathway characteristics

Device Classification

Product Code OYO Culture, Intravaginal, Assisted Reproduction
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.6165
Definition Intravaginal Culture Of Human Gametes And Embryos. To Hold And Maintain Gametes And Developing Embryos Over The Duration Of The Intravaginal Culture Period.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.