Cleared Traditional

K945131 - IMAGYN INTRAUTERINE INSEMINATION DEVICE

K945131 is an FDA 510(k) clearance for IMAGYN INTRAUTERINE INSEMINATION DEVICE, manufactured by Imagyn Medical, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HDR cleared through the Traditional 510(k) pathway after a 208-day FDA review.

K945131 · Imagyn Medical, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1995
Decision
208d
Days
Class 2
Risk

K945131 is an FDA 510(k) clearance for the IMAGYN INTRAUTERINE INSEMINATION DEVICE. Classified as Cap, Cervical (product code HDR), Class II - Special Controls.

Submitted by Imagyn Medical, Inc. (Laguna Niguel, US). The FDA issued a Cleared decision on May 15, 1995 after a review of 208 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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 Imagyn Medical, Inc. devices

FDA 510(k) Submission Details - K945131

510(k) Number K945131 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 1994
Decision Date May 15, 1995
Days to Decision 208 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d slower than avg
Panel avg: 160d · This submission: 208d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HDR Device Classification - Class 2, Special Controls

Product Code HDR Cap, Cervical
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 - HDR Cap, Cervical

All 12
Devices cleared under the same product code (HDR) and FDA review panel - the closest regulatory comparables to K945131.
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K902694 · Cook Ob/Gyn · Aug 1990
INTRAUTERINE INSEMINATION CATHETERS
K896960 · C.R. Bard, Inc. · Jun 1990