Cleared Traditional

K992307 - EMBRYO GLIDE EMBRYO TRANSFER CATHETER, EMBRYO GLIDE STYLE FOR EMBRYO TRANSFER CATHETER

K992307 is an FDA 510(k) clearance for EMBRYO GLIDE EMBRYO TRANSFER CATHETER, manufactured by Fertility Technology Resources, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code MQF cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K992307 · Fertility Technology Resources, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1999
Decision
66d
Days
Class 2
Risk

K992307 is an FDA 510(k) clearance for the EMBRYO GLIDE EMBRYO TRANSFER CATHETER, EMBRYO GLIDE STYLE FOR EMBRYO TRANSFER.... Classified as Catheter, Assisted Reproduction (product code MQF), Class II - Special Controls.

Submitted by Fertility Technology Resources, Inc. (Marietta, US). The FDA issued a Cleared decision on September 13, 1999 after a review of 66 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 Fertility Technology Resources, Inc. devices

FDA 510(k) Submission Details - K992307

510(k) Number K992307 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 1999
Decision Date September 13, 1999
Days to Decision 66 days
Submission Type Traditional
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
94d faster than avg
Panel avg: 160d · This submission: 66d
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 28
Devices cleared under the same product code (MQF) and FDA review panel - the closest regulatory comparables to K992307.
Soules Intrauterine Insemination Catheter
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EMBRYON GIFT TRANSFER CATHETERS/SETS
K000656 · Rocket Medical Plc · Mar 2000
EMBRYON TRANSFER CATHETERS/SETS
K994327 · Rocket Medical Plc · Feb 2000
EMBRYO TRANSFER CATHETER CC GLIDER
K991266 · Intl., Inc. · Sep 1999
WALLACE TRIAL TRANSFER CATHETER, MODEL TT 1816N
K990348 · CooperSurgical, Inc. · Jul 1999
WALLACE MALLEABLE STYLET-18CM, MODEL 1816ST, WALLACE MALLEABLE STYLET-23CM, MODEL 1816NST
K990349 · CooperSurgical, Inc. · Jul 1999