Cleared Traditional

K994327 - EMBRYON TRANSFER CATHETERS/SETS

K994327 is an FDA 510(k) clearance for EMBRYON TRANSFER CATHETERS/SETS, manufactured by Rocket Medical Plc. The device is a Class 2 Obstetrics & Gynecology device with product code MQF cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K994327 · Rocket Medical Plc · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2000
Decision
68d
Days
Class 2
Risk

K994327 is an FDA 510(k) clearance for the EMBRYON TRANSFER CATHETERS/SETS. Classified as Catheter, Assisted Reproduction (product code MQF), Class II - Special Controls.

Submitted by Rocket Medical Plc (Washington, GB). The FDA issued a Cleared decision on February 28, 2000 after a review of 68 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 Rocket Medical Plc devices

FDA 510(k) Submission Details - K994327

510(k) Number K994327 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1999
Decision Date February 28, 2000
Days to Decision 68 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
92d faster than avg
Panel avg: 160d · This submission: 68d
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 25
Devices cleared under the same product code (MQF) and FDA review panel - the closest regulatory comparables to K994327.
Guardia™ Access Nano and Soft-Trans Embryo Transfer Catheter Sets, Soft-Trans Embryo Transfer Catheter, Soft-Trans Guide Catheter
K172051 · Cook Incorporated · Jan 2018
Shepard, Insemi-Cath, and Soft-Pass Coaxial - Cook Intrauterine Insemination Catheters
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Soules Intrauterine Insemination Catheter
K163318 · Cook Incorporated · Jul 2017
EMBRYO TRANSFER CATHETER CC GLIDER
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WALLACE TRIAL TRANSFER CATHETER, MODEL TT 1816N
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WALLACE MALLEABLE STYLET-18CM, MODEL 1816ST, WALLACE MALLEABLE STYLET-23CM, MODEL 1816NST
K990349 · CooperSurgical, Inc. · Jul 1999