Cleared Traditional

K914150 - JANSEN-ANDERSON INSEMINATION SET

K914150 is an FDA 510(k) clearance for JANSEN-ANDERSON INSEMINATION SET, manufactured by Cook Ob/Gyn. The device is a Class 2 Obstetrics & Gynecology device with product code MFD cleared through the Traditional 510(k) pathway after a 352-day FDA review.

K914150 · Cook Ob/Gyn · Obstetrics & Gynecology device
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Sep 1992
Decision
352d
Days
Class 2
Risk

K914150 is an FDA 510(k) clearance for the JANSEN-ANDERSON INSEMINATION SET. Classified as Cannula, Intrauterine Insemination (product code MFD), Class II - Special Controls.

Submitted by Cook Ob/Gyn (Spencer, US). The FDA issued a Cleared decision on September 2, 1992 after a review of 352 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. 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.

FDA 510(k) Submission Details - K914150

510(k) Number K914150 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 1991
Decision Date September 02, 1992
Days to Decision 352 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
191d slower than avg
Panel avg: 161d · This submission: 352d
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.

Regulatory Peers - MFD Cannula, Intrauterine Insemination

All 28
Devices cleared under the same product code (MFD) and FDA review panel - the closest regulatory comparables to K914150.
MODIFIED F-10 CULTURE MEDIUM
K923634 · Life-Tech Intl., Inc. · Sep 1993
DISTILLED WATER
K923651 · Life-Tech Intl., Inc. · Sep 1993
DULBECCO'S PHOSPHATE BUFFERED SALINE
K923652 · Life-Tech Intl., Inc. · Sep 1993
EDWARDS-WALLACE BOURNE HALL CATHETER
K910577 · Marlo Surgical Technology · May 1991
UNI-SEM(TM)
K910317 · Unimar, Inc. · May 1991
SEMINOR
K905764 · Promedex, Inc. · Mar 1991
K914150 · JANSEN-ANDERSON INSEMINATION SET
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