Cleared Traditional

K240247 - “MoFi” Cell Culture Basal Medium

K240247 is an FDA 510(k) clearance for “MoFi” Cell Culture Basal Medium, manufactured by Duogenic Stemcells Corporation. The device is a Class 2 Gastroenterology & Urology device with product code NDS cleared through the Traditional 510(k) pathway after a 164-day FDA review.

K240247 · Duogenic Stemcells Corporation · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2024
Decision
164d
Days
Class 2
Risk

K240247 is an FDA 510(k) clearance for the “MoFi” Cell Culture Basal Medium. Classified as Media, Culture, Ex Vivo, Tissue And Cell (product code NDS), Class II - Special Controls.

Submitted by Duogenic Stemcells Corporation (Taichung City, TW). The FDA issued a Cleared decision on July 12, 2024 after a review of 164 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5885 - the FDA gastroenterology and urology 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 Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Duogenic Stemcells Corporation devices

FDA 510(k) Submission Details - K240247

510(k) Number K240247 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 2024
Decision Date July 12, 2024
Days to Decision 164 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
33d slower than avg
Panel avg: 131d · This submission: 164d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NDS Device Classification - Class 2, Special Controls

Product Code NDS Media, Culture, Ex Vivo, Tissue And Cell
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5885
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - NDS Media, Culture, Ex Vivo, Tissue And Cell

All 8
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