Cleared Abbreviated

K053208 - CLEAR VISION EMBRYO TRANSFER CATHETER SET, MODEL B100000 - B 100007

Also marketed or referenced as:
CLEAR VISION TRIAL TRANSFER CATHETER SET

K053208 is an FDA 510(k) clearance for CLEAR VISION EMBRYO TRANSFER CATHETER SET, manufactured by Swemed Lab International AB. The device is a Class 2 Obstetrics & Gynecology device with product code MQF cleared through the Abbreviated 510(k) pathway after a 75-day FDA review.

K053208 · Swemed Lab International AB · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2006
Decision
75d
Days
Class 2
Risk

K053208 is an FDA 510(k) clearance for the CLEAR VISION EMBRYO TRANSFER CATHETER SET, MODEL B100000 - B 100007. Classified as Catheter, Assisted Reproduction (product code MQF), Class II - Special Controls.

Submitted by Swemed Lab International AB (Billdal, SE). The FDA issued a Cleared decision on January 30, 2006 after a review of 75 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 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.

FDA 510(k) Submission Details - K053208

510(k) Number K053208 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 2005
Decision Date January 30, 2006
Days to Decision 75 days
Submission Type Abbreviated
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
86d faster than avg
Panel avg: 161d · This submission: 75d
Pathway characteristics
Standards-based clearance path.

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 K053208.
IUI CATHETERS
K112396 · Kitazato Medical Co., Ltd. · Nov 2012
INTRAUTERINE INSEMINATION (IUI) CATHETER
K120154 · Catheter Research, Inc. · Mar 2012
INTRAUTERINE INSEMINATION (IUI) CATHETER
K092579 · Fertiligent, Ltd. · Apr 2010
IUI CATHETER, MODEL 9057
K052059 · Inntec, Inc. · Nov 2005
EMBRYO TRANSFER CATHETER WITH ACCESSORY STYLET, MODELS 9018, 9023, 9018-S, 9023-S
K050521 · Inntec, Inc. · May 2005
MORTON IUI CATHETERS
K041470 · Fertility Technology Resources, Inc. · Nov 2004
K053208 · CLEAR VISION EMBRYO TRANSFER CATHETER SET, MODEL B100000 - B 100007
Download PDF FDA Summary Swemed Lab Internatio…