Cleared Traditional

K000205 - EMBRYON SINGLE AND DOUBLE LUMEN NEEDLES

K000205 is an FDA 510(k) clearance for EMBRYON SINGLE AND DOUBLE LUMEN NEEDLES, manufactured by Rocket Medical Plc. The device is a Class 2 Obstetrics & Gynecology device with product code MQE cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K000205 · Rocket Medical Plc · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2000
Decision
89d
Days
Class 2
Risk

K000205 is an FDA 510(k) clearance for the EMBRYON SINGLE AND DOUBLE LUMEN NEEDLES. 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 April 19, 2000 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.6100 - 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 - K000205

510(k) Number K000205 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 2000
Decision Date April 19, 2000
Days to Decision 89 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
72d faster than avg
Panel avg: 161d · This submission: 89d
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 Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - MQE Needle, Assisted Reproduction

All 30
Devices cleared under the same product code (MQE) and FDA review panel - the closest regulatory comparables to K000205.
FAS SET #4551
K013497 · Gynetics Medical Products NV · Nov 2001
WALLACE OOCYTE RETRIEVAL SETS 16G, WALLACE OOCYTE RETRIEVAL SET 17G, MODELS MEONS 1633S, MEONS 1733S
K012068 · Sims Portex , Ltd. · Aug 2001
OVARIAL BIOPSY SET 324102-324108
K003056 · Labotect Labor-Technik Gottingen · Dec 2000
WALLACE OOCYTE RETRIEVAL SET-16G, MODEL MEONS1633
K000628 · Sims Portex , Ltd. · Mar 2000
OOCYTE ASPIRATION NEEDLE
K991271 · Casmed UK · Mar 2000
OVUM PICK-UP NEEDLES WITH AQ COATING, ASPIRATION NEEDLES WITH AQ COATING
K994417 · Cook Urological, Inc. · Mar 2000