Cleared Traditional

K931630 - INSEMI-CATH

K931630 is an FDA 510(k) clearance for INSEMI-CATH, 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 382-day FDA review.

K931630 · Cook Ob/Gyn · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
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.

FDA 510(k) Submission Details - K931630

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
221d slower than avg
Panel avg: 161d · This submission: 382d
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 K931630.
MODIFIED HUMAN TUBAL FLUID (MHTF) WITH/WITHOUT PENICILLIN G DOLIUM, WITH/WITHOUT STREPTOMYCIN SULFATE
K951835 · Life Technologies, Inc. · Aug 1995
INTRAUTERINE CATHETER AND INTRODUCER
K932993 · Conceptus, Inc. · Jan 1995
LIFETEK IUI CATHETER
K921518 · Lifetek Medical, Inc. · May 1994
SPERM MAINTENANCE MEDIUM WITH GLYCEROL
K914541 · Irvine Scientific · Feb 1994
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
K931630 · INSEMI-CATH
Download PDF FDA Summary Cook Ob/Gyn