Cleared Traditional

K931630 - INSEMI-CATH

K931630 is the FDA 510(k) clearance for INSEMI-CATH by Cook Ob/Gyn. It is a Class 2 Obstetrics & Gynecology device (product code MFD) cleared through the Traditional 510(k) pathway after a 382-day FDA review.

K931630 · Cook Ob/Gyn · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Apr 1994
Decision
382d
Days
Class 2
Risk

K931630 is an FDA 510(k) clearance for the INSEMI-CATH. 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 April 19, 1994 after a review of 382 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.

View all Cook Ob/Gyn devices

Submission Details

510(k) Number K931630 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 1993
Decision Date April 19, 1994
Days to Decision 382 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
222d slower than avg
Panel avg: 160d · This submission: 382d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 7
Devices cleared under the same product code (MFD) and FDA review panel - the closest regulatory comparables to K931630.
ACKRAD IUI SET FOR INTRAUTERINE INSEMINATION
K940176 · Ackrad Laboratories · Apr 1996
INSEMI-CATH II
K954398 · Cook Urological, Inc. · Dec 1995
MODIFIED F-10 CULTURE MEDIUM W/O HYPOXANTHINE
K923612 · Life-Tech Intl., Inc. · Sep 1993
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