Cleared Traditional

K905764 - SEMINOR

K905764 is an FDA 510(k) clearance for SEMINOR, manufactured by Promedex, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code MFD cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K905764 · Promedex, Inc. · Obstetrics & Gynecology device
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Mar 1991
Decision
75d
Days
Class 2
Risk

K905764 is an FDA 510(k) clearance for the SEMINOR. Classified as Cannula, Intrauterine Insemination (product code MFD), Class II - Special Controls.

Submitted by Promedex, Inc. (Fort Woth, US). The FDA issued a Cleared decision on March 12, 1991 after a review of 75 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5250 - 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 Promedex, Inc. devices

FDA 510(k) Submission Details - K905764

510(k) Number K905764 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1990
Decision Date March 12, 1991
Days to Decision 75 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 160d · This submission: 75d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MFD Device Classification - Class 2, Special Controls

Product Code MFD Cannula, Intrauterine Insemination
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.5250
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.