Cleared Abbreviated

K021438 - INSEMINATION CATHETER, MODEL 320301

K021438 is an FDA 510(k) clearance for INSEMINATION CATHETER, manufactured by Labotect Labor-Technik Gottingen. The device is a Class 2 Obstetrics & Gynecology device with product code MFD cleared through the Abbreviated 510(k) pathway after a 71-day FDA review.

K021438 · Labotect Labor-Technik Gottingen · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K021438

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.

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 20
Devices cleared under the same product code (MFD) and FDA review panel - the closest regulatory comparables to K021438.
`THE INSEMINATOR' (PROPOSED)
K984306 · Wallach Surgical Devices, Inc. · Mar 1999
MEDWORKS VISUALIZATION INSEMINATION CATHETER
K982630 · Medworks Corp. · Jan 1999
MEDWORKS INSEMINATION CATHETER
K982628 · Medworks Corp. · Aug 1998
EMBRYON INTRAUTERINE INSEMINATION CATHETER, EMRYON SOFT INTRAUTERINE INSEMINATION CATHETER, STYLET FOR EMBRYON INTRAUTER
K980061 · Rocket Medical Plc · Mar 1998
MINI-EMBRYON INTRA UTERINE INSEMINATION CATHETER
K972823 · A & A Medical, Inc. · Oct 1997
TOM CAT F.L., TOM CAT S.L.
K972245 · A & A Medical, Inc. · Aug 1997