Cleared Traditional

CaseMONO? Culture (CMON); CaseMONO? w/HEPES (WHMO); CaseBioscience? HTF (HTFC); CaseBioscience? HTF w/HEPES (HHTF)

K242107 · Casebioscience, Inc. · Obstetrics & Gynecology

Mar 2025

Decision

246d

Days

Class 2

Risk

About This 510(k) Submission

K242107 is an FDA 510(k) clearance for the CaseMONO? Culture (CMON); CaseMONO? w/HEPES (WHMO); CaseBioscience? HTF (HTFC); CaseBioscience? HTF w/HEPES (HHTF), a Media, Reproductive (Class II — Special Controls, product code MQL), submitted by Casebioscience, Inc. (Guelph, CA). The FDA issued a Cleared decision on March 21, 2025, 246 days after receiving the submission on July 18, 2024. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.6180.

Submission Details

510(k) Number	K242107 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 18, 2024
Decision Date	March 21, 2025
Days to Decision	246 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Summary PDF