Cleared Abbreviated

INSEMINATION CATHETER, MODEL 320301 (K021438) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K021438 · Labotect Labor-Technik Gottingen · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
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Jul 2002
Decision
71d
Days
Class 2
Risk

K021438 is an FDA 510(k) clearance for the INSEMINATION CATHETER, MODEL 320301. Classified as Cannula, Intrauterine Insemination (product code MFD), Class II - Special Controls.

Submitted by Labotect Labor-Technik Gottingen (Gottingen, DE). The FDA issued a Cleared decision on July 16, 2002 after a review of 71 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Labotect Labor-Technik Gottingen devices

Submission Details

510(k) Number K021438 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 2002
Decision Date July 16, 2002
Days to Decision 71 days
Submission Type Abbreviated
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 160d · This submission: 71d
Pathway characteristics
Standards-based clearance path.

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.