Cleared Traditional

K012220 - TAO EMBRYO TRANSFER CATHETER SYSTEM

K012220 is an FDA 510(k) clearance for TAO EMBRYO TRANSFER CATHETER SYSTEM, manufactured by Ttj Biomedical, LLC. The device is a Class 2 Obstetrics & Gynecology device with product code MQF cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K012220 · Ttj Biomedical, LLC · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2001
Decision
42d
Days
Class 2
Risk

K012220 is an FDA 510(k) clearance for the TAO EMBRYO TRANSFER CATHETER SYSTEM. Classified as Catheter, Assisted Reproduction (product code MQF), Class II - Special Controls.

Submitted by Ttj Biomedical, LLC (Boulder, US). The FDA issued a Cleared decision on August 27, 2001 after a review of 42 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.

View all Ttj Biomedical, LLC devices

FDA 510(k) Submission Details - K012220

510(k) Number K012220 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 2001
Decision Date August 27, 2001
Days to Decision 42 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
118d faster than avg
Panel avg: 160d · This submission: 42d
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 38
Devices cleared under the same product code (MQF) and FDA review panel - the closest regulatory comparables to K012220.
KITAZATO IUI CATHETER
K131491 · Kitazato Medical Co., Ltd. · Sep 2013
IUI CATHETERS
K112396 · Kitazato Medical Co., Ltd. · Nov 2012
INTRAUTERINE INSEMINATION (IUI) CATHETER
K120154 · Catheter Research, Inc. · Mar 2012
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