Cleared Traditional

K022330 - ALLGRAD 45 AND 90 CELL SEPARATION MEDIA

K022330 is the FDA 510(k) clearance for ALLGRAD 45 AND 90 CELL SEPARATION MEDIA by Intl., Inc.. It is a Class 2 Obstetrics & Gynecology device (product code MQL) cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K022330 · Intl., Inc. · Obstetrics & Gynecology device
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Aug 2002
Decision
39d
Days
Class 2
Risk

K022330 is an FDA 510(k) clearance for the ALLGRAD 45 AND 90 CELL SEPARATION MEDIA. Classified as Media, Reproductive (product code MQL), Class II - Special Controls.

Submitted by <Genx> Intl., Inc. (Guilford, US). The FDA issued a Cleared decision on August 26, 2002 after a review of 39 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Intl., Inc. devices

Submission Details

510(k) Number K022330 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 2002
Decision Date August 26, 2002
Days to Decision 39 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
121d faster than avg
Panel avg: 160d · This submission: 39d
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

Intl., Inc.
MICHAEL D CECCHI

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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