Cleared Traditional

K161970 - Follicle Aspiration Set (FDA 510(k) Clearance)

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

K161970 · Vitrolife Sweden AB · Obstetrics & Gynecology device
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Jun 2017
Decision
331d
Days
Class 2
Risk

K161970 is an FDA 510(k) clearance for the Follicle Aspiration Set. Classified as Needle, Assisted Reproduction (product code MQE), Class II - Special Controls.

Submitted by Vitrolife Sweden AB (Västra Frölunda, SE). The FDA issued a Cleared decision on June 14, 2017 after a review of 331 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Vitrolife Sweden AB devices

Submission Details

510(k) Number K161970 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 2016
Decision Date June 14, 2017
Days to Decision 331 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
171d slower than avg
Panel avg: 160d · This submission: 331d
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 K161970.
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
Wallace Dual Lumen Oocyte Recovery System
K191291 · CooperSurgical, Inc. · Jun 2019
Wallace Dual Lumen Oocyte Recovery System
K182959 · CooperSurgical, Inc. · May 2019