Cleared Traditional

CaseMONO™ Culture (CMON) (K242107) - FDA 510(k) Clearance

Also marketed or referenced as:
CaseMONO™ w/HEPES (WHMO) CaseBioscience® HTF (HTFC) CaseBioscience® HTF w/HEPES (HHTF)

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K242107 · Casebioscience, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2025
Decision
246d
Days
Class 2
Risk

K242107 is an FDA 510(k) clearance for the CaseMONO™ Culture (CMON). Classified as Media, Reproductive (product code MQL), Class II - Special Controls.

Submitted by Casebioscience, Inc. (Guelph, CA). The FDA issued a Cleared decision on March 21, 2025 after a review of 246 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.6180 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Casebioscience, Inc. devices

Submission Details

510(k) Number K242107 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
86d slower than avg
Panel avg: 160d · This submission: 246d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MQL Media, Reproductive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.6180
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.

Regulatory Peers - MQL Media, Reproductive

All 50
Devices cleared under the same product code (MQL) and FDA review panel - the closest regulatory comparables to K242107.
Vitrification Freeze Kit (RFD-0101) Vitrification Thaw Kit (RFD-0201, RFD-0202)
K242089 · Jiangsu Ruifuda Medical Device Co., Ltd. · Apr 2025
Dewin Reproductive Media (Dewin Vitrification Kit, Dewin Thawing Kit)
K242561 · Donnevie Medical Technology (Shanghai) Co. , Ltd. · Apr 2025
V-GRAD
K241833 · Vitromed GmbH · Mar 2025
Sperm Freezing Medium
K242043 · Gimbo Medical Technology Shenzhen Co., Ltd. · Jan 2025
ARTSMedia Semen Wash Medium
K241095 · Artsmedia Denmark Aps · Dec 2024
ARTSMedia Oocyte Aspiration Medium (502020, 502050, 502100)
K241132 · Artsmedia Denmark Aps · Dec 2024