Cleared Traditional

K082727 - FOLLICLE ASPIRATION SET, REDUCED SINGLE LUMEN

K082727 is an FDA 510(k) clearance for FOLLICLE ASPIRATION SET, manufactured by Vitrolife Sweden AB. The device is a Class 2 Obstetrics & Gynecology device with product code MQE cleared through the Traditional 510(k) pathway after a 142-day FDA review.

K082727 · Vitrolife Sweden AB · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2009
Decision
142d
Days
Class 2
Risk

K082727 is an FDA 510(k) clearance for the FOLLICLE ASPIRATION SET, REDUCED SINGLE LUMEN. Classified as Needle, Assisted Reproduction (product code MQE), Class II - Special Controls.

Submitted by Vitrolife Sweden AB (Kungsbacka, SE). The FDA issued a Cleared decision on February 6, 2009 after a review of 142 days - within the typical 510(k) review window.

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 Vitrolife Sweden AB devices

FDA 510(k) Submission Details - K082727

510(k) Number K082727 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 2008
Decision Date February 06, 2009
Days to Decision 142 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
18d faster than avg
Panel avg: 160d · This submission: 142d
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 26
Devices cleared under the same product code (MQE) and FDA review panel - the closest regulatory comparables to K082727.
Follicle Aspiration Set
K161970 · Vitrolife Sweden AB · Jun 2017
OTRIEVA TAPERED OVUM ASPIRATION NEEDLE SINGLE LUMEN
K141365 · William A. Cook Australia Pty. , Ltd. · Aug 2014
KITAZATO OPU NEEDLE
K112462 · Kitazato Medical Co., Ltd. · Nov 2012
OOCYTE RETRIEVAL NEEDLE SET, MODELS 917-IH AND 917-SH
K051742 · Inntec, Inc. · Oct 2005
EMBRYON ULTRASOUND NEEDLE GUIDE
K032015 · Rocket Medical Plc · Aug 2003
COOPERSURGICAL OOCYTE RECOVERY NEEDLES
K023930 · CooperSurgical, Inc. · Jan 2003