Cleared Traditional

K250445 - Fast Warm - NX (FDA 510(k) Clearance)

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

K250445 · Fujifilm Irvine Scientific · Obstetrics & Gynecology device
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Sep 2025
Decision
210d
Days
Class 2
Risk

K250445 is an FDA 510(k) clearance for the Fast Warm - NX. Classified as Media, Reproductive (product code MQL), Class II - Special Controls.

Submitted by Fujifilm Irvine Scientific (Santa Ana, US). The FDA issued a Cleared decision on September 12, 2025 after a review of 210 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 Fujifilm Irvine Scientific devices

Submission Details

510(k) Number K250445 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 2025
Decision Date September 12, 2025
Days to Decision 210 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
50d slower than avg
Panel avg: 160d · This submission: 210d
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 258
Devices cleared under the same product code (MQL) and FDA review panel - the closest regulatory comparables to K250445.
Ultra-Fast Warm
K260248 · Kitazato Corporation · Apr 2026
CaseBio™ Culture w/HSA (CMH5)
K252672 · Casebioscience, Inc. · Feb 2026
Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]
K251637 · Donnevie Medical Technology (Shanghai) Co. , Ltd. · Aug 2025
Ultra-Fast Vitri
K251305 · Kitazato Corporation · Aug 2025
FertiCult Flushing medium
K242640 · Fertipro NV · May 2025
Vitrification Freeze Kit (RFD-0101) Vitrification Thaw Kit (RFD-0201, RFD-0202)
K242089 · Jiangsu Ruifuda Medical Device Co., Ltd. · Apr 2025