Cleared Traditional

VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro® Double Lumen Oocyte Retrieval Needle (ORND-17G) (K240523) - FDA 510(k) Clearance

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

K240523 · Shenzhen Vitavitro Biotech Co., Ltd. · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Nov 2024
Decision
266d
Days
Class 2
Risk

K240523 is an FDA 510(k) clearance for the VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVit.... Classified as Needle, Assisted Reproduction (product code MQE), Class II - Special Controls.

Submitted by Shenzhen Vitavitro Biotech Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on November 15, 2024 after a review of 266 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Shenzhen Vitavitro Biotech Co., Ltd. devices

Submission Details

510(k) Number K240523 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 2024
Decision Date November 15, 2024
Days to Decision 266 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
106d slower than avg
Panel avg: 160d · This submission: 266d
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

Devices cleared under the same product code (MQE) and FDA review panel - the closest regulatory comparables to K240523.
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