Cleared Traditional

K190152 - Vit Kit- Freeze NX and Vit Kit- Warm NX

K190152 is the FDA 510(k) clearance for Vit Kit- Freeze NX and Vit Kit- Warm NX by Fujifilm Irvine Scientific, Inc.. It is a Class 2 Obstetrics & Gynecology device (product code MQL) cleared through the Traditional 510(k) pathway after a 142-day FDA review.

K190152 · Fujifilm Irvine Scientific, Inc. · Obstetrics & Gynecology device
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Jun 2019
Decision
142d
Days
Class 2
Risk

K190152 is an FDA 510(k) clearance for the Vit Kit- Freeze NX and Vit Kit- Warm NX. Classified as Media, Reproductive (product code MQL), Class II - Special Controls.

Submitted by Fujifilm Irvine Scientific, Inc. (Santa Ana, US). The FDA issued a Cleared decision on June 21, 2019 after a review of 142 days - within the typical 510(k) review window.

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, Inc. devices

Submission Details

510(k) Number K190152 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 2019
Decision Date June 21, 2019
Days to Decision 142 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
18d faster than avg
Panel avg: 160d · This submission: 142d
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 Consultant

Fujifilm Irine Scientific, Inc.
Jayme Yamaguchi-Owens

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MQL Media, Reproductive

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