Cleared Traditional

K032015 - EMBRYON ULTRASOUND NEEDLE GUIDE

K032015 is an FDA 510(k) clearance for EMBRYON ULTRASOUND NEEDLE GUIDE, manufactured by Rocket Medical Plc. The device is a Class 2 Radiology device with product code MQE cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K032015 · Rocket Medical Plc · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2003
Decision
39d
Days
Class 2
Risk

K032015 is an FDA 510(k) clearance for the EMBRYON ULTRASOUND NEEDLE GUIDE. Classified as Needle, Assisted Reproduction (product code MQE), Class II - Special Controls.

Submitted by Rocket Medical Plc (Washington, Tyne & Wear, GB). The FDA issued a Cleared decision on August 8, 2003 after a review of 39 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 884.6100 - the FDA radiology and imaging software oversight 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 - K032015

510(k) Number K032015 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 2003
Decision Date August 08, 2003
Days to Decision 39 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 107d · This submission: 39d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQE Device Classification - Class 2, Special Controls

Product Code MQE Needle, Assisted Reproduction
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.6100
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 Radiology devices follow this clearance model.

Regulatory Peers - MQE Needle, Assisted Reproduction

All 15
Devices cleared under the same product code (MQE) and FDA review panel - the closest regulatory comparables to K032015.
Follicle Aspiration Set, Reduced Single Lumen
K172050 · Vitrolife Sweden AB · Nov 2017
Follicle Aspiration Set
K161970 · Vitrolife Sweden AB · Jun 2017
FOLLICLE ASPIRATION SET, REDUCED SINGLE LUMEN
K082727 · Vitrolife Sweden AB · Feb 2009
COOPERSURGICAL OOCYTE RECOVERY NEEDLES
K023930 · CooperSurgical, Inc. · Jan 2003
OVUM PICK-UP NEEDLES WITH AQ COATING, ASPIRATION NEEDLES WITH AQ COATING
K994417 · Cook Urological, Inc. · Mar 2000
DOUBLE LUMEN NEEDLE
K991020 · Intl., Inc. · Sep 1999