Cleared Traditional

K023106 - PROMOTOR

K023106 is an FDA 510(k) clearance for PROMOTOR, manufactured by Ceres Fertility, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code MQL cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K023106 · Ceres Fertility, Inc. · Obstetrics & Gynecology device
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Nov 2002
Decision
48d
Days
Class 2
Risk

K023106 is an FDA 510(k) clearance for the PROMOTOR. Classified as Media, Reproductive (product code MQL), Class II - Special Controls.

Submitted by Ceres Fertility, Inc. (Irvine, US). The FDA issued a Cleared decision on November 5, 2002 after a review of 48 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 Ceres Fertility, Inc. devices

FDA 510(k) Submission Details - K023106

510(k) Number K023106 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 2002
Decision Date November 05, 2002
Days to Decision 48 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
112d faster than avg
Panel avg: 160d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQL Device Classification - Class 2, Special Controls

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 197
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