Cleared Traditional

K000950 - EMBRYO TRANSFER CATHETER SET, MODEL 320200 AND 320201

K000950 is an FDA 510(k) clearance for EMBRYO TRANSFER CATHETER SET, manufactured by Labotect Labor-Technik Gottingen. The device is a Class 2 Obstetrics & Gynecology device with product code MQF cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K000950 · Labotect Labor-Technik Gottingen · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2000
Decision
50d
Days
Class 2
Risk

K000950 is an FDA 510(k) clearance for the EMBRYO TRANSFER CATHETER SET, MODEL 320200 AND 320201. Classified as Catheter, Assisted Reproduction (product code MQF), Class II - Special Controls.

Submitted by Labotect Labor-Technik Gottingen (Gottingen, DE). The FDA issued a Cleared decision on May 12, 2000 after a review of 50 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.6110 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K000950

510(k) Number K000950 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 2000
Decision Date May 12, 2000
Days to Decision 50 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
111d faster than avg
Panel avg: 161d · This submission: 50d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQF Device Classification - Class 2, Special Controls

Product Code MQF Catheter, Assisted Reproduction
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.6110
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 - MQF Catheter, Assisted Reproduction

All 52
Devices cleared under the same product code (MQF) and FDA review panel - the closest regulatory comparables to K000950.
IUI, MODEL 4220
K013501 · Gynetics Medical Products NV · Nov 2001
EMTRAC
K013536 · Gynetics Medical Products NV · Nov 2001
TAO EMBRYO TRANSFER CATHETER SYSTEM
K012220 · Ttj Biomedical, LLC · Aug 2001
EMBRYON GIFT TRANSFER CATHETERS/SETS
K000656 · Rocket Medical Plc · Mar 2000
EMBRYON TRANSFER CATHETERS/SETS
K994327 · Rocket Medical Plc · Feb 2000
EMBRYO GLIDE EMBRYO TRANSFER CATHETER, EMBRYO GLIDE STYLE FOR EMBRYO TRANSFER CATHETER
K992307 · Fertility Technology Resources, Inc. · Sep 1999
K000950 · EMBRYO TRANSFER CATHETER SET, MODEL 320200 AND 320201
Download PDF FDA Summary Labotect Labor-Techni…