Cleared Abbreviated

K231804 - PRIME-XV FreezIS DMSO-Free MD (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K231804 · Fujifilm Irvine Scientific · Gastroenterology & Urology device
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Nov 2023
Decision
142d
Days
Class 2
Risk

K231804 is an FDA 510(k) clearance for the PRIME-XV FreezIS DMSO-Free MD. Classified as Media, Culture, Ex Vivo, Tissue And Cell (product code NDS), Class II - Special Controls.

Submitted by Fujifilm Irvine Scientific (Santa Ana, US). The FDA issued a Cleared decision on November 9, 2023 after a review of 142 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5885 - the FDA gastroenterology and urology device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Fujifilm Irvine Scientific devices

Submission Details

510(k) Number K231804 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 2023
Decision Date November 09, 2023
Days to Decision 142 days
Submission Type Abbreviated
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
12d slower than avg
Panel avg: 130d · This submission: 142d
Pathway characteristics
Standards-based clearance path.

Device Classification

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.