Cleared Traditional

WALLACE OOCYTE RETRIEVAL SETS 16G, WALLACE OOCYTE RETRIEVAL SET 17G, MODELS MEONS 1633S, MEONS 1733S (K012068) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K012068 · Sims Portex , Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2001
Decision
32d
Days
Class 2
Risk

K012068 is an FDA 510(k) clearance for the WALLACE OOCYTE RETRIEVAL SETS 16G, WALLACE OOCYTE RETRIEVAL SET 17G, MODELS M.... Classified as Needle, Assisted Reproduction (product code MQE), Class II - Special Controls.

Submitted by Sims Portex , Ltd. (Hythe, Kent, GB). The FDA issued a Cleared decision on August 3, 2001 after a review of 32 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 Sims Portex , Ltd. devices

Submission Details

510(k) Number K012068 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2001
Decision Date August 03, 2001
Days to Decision 32 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
128d faster than avg
Panel avg: 160d · This submission: 32d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 31
Devices cleared under the same product code (MQE) and FDA review panel - the closest regulatory comparables to K012068.
VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro® Double Lumen Oocyte Retrieval Needle (ORND-17G)
K240523 · Shenzhen Vitavitro Biotech Co., Ltd. · Nov 2024
Lotus Single Lumen Ovum Aspiration Needle
K232163 · Zhejiang Horizon Medical Technology Co., Ltd. · Feb 2024
Allwin Ovum Pickup Needles (ACE Single Lumen Ovum Pickup Needle, OVUMPICK Double Lumen Ovum Pickup Needle, ACE-FL Single Lumen Ovum Pickup Needle with Flushing Line, ACE-M Manual Single Lumen Ovum Pickup Needle)
K190590 · Allwin Medical Devices, Inc. · Nov 2019
Wallace Dual Lumen Oocyte Recovery System
K191291 · CooperSurgical, Inc. · Jun 2019
Wallace Dual Lumen Oocyte Recovery System
K182959 · CooperSurgical, Inc. · May 2019
Single Lumen Ovum Aspiration Needles
K171625 · Willian A. Cook Australia Pty, Ltd. · Jan 2018