Cleared Traditional

K092183 - EMBRYOSCOPE AND EMBRYOSLIDE

K092183 is an FDA 510(k) clearance for EMBRYOSCOPE AND EMBRYOSLIDE, manufactured by Unisense Fertilitech A/S. The device is a Class 2 Obstetrics & Gynecology device with product code MQG cleared through the Traditional 510(k) pathway after a 539-day FDA review.

K092183 · Unisense Fertilitech A/S · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2011
Decision
539d
Days
Class 2
Risk

K092183 is an FDA 510(k) clearance for the EMBRYOSCOPE AND EMBRYOSLIDE. Classified as Accessory, Assisted Reproduction (product code MQG), Class II - Special Controls.

Submitted by Unisense Fertilitech A/S (Arrhus, DK). The FDA issued a Cleared decision on January 11, 2011 after a review of 539 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.6120 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Obstetrics & Gynecology submissions.

FDA 510(k) Submission Details - K092183

510(k) Number K092183 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 2009
Decision Date January 11, 2011
Days to Decision 539 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
378d slower than avg
Panel avg: 161d · This submission: 539d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQG Device Classification - Class 2, Special Controls

Product Code MQG Accessory, Assisted Reproduction
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.6120
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 - MQG Accessory, Assisted Reproduction

All 46
Devices cleared under the same product code (MQG) and FDA review panel - the closest regulatory comparables to K092183.
EMBRYO VIEWER SOFTWARE
K113075 · Unisense Fertilitech A/S · Dec 2011
EMBRYOSCOPE
K111715 · Unisense Fertilitech A/S · Aug 2011
HEAL FORCE CO2 INCUBATOR
K101988 · Shanghai Lishen Scientific Equipment Co., Ltd. · Feb 2011
MINITUBE TEMPERATURE CONTROL UNIT SC-2000 + 2045
K050197 · Minitube of America, Inc. · Oct 2006
ZIVF-AIRE
K041952 · Zander Medical Supplies, Inc. · Sep 2005
KRYO ART CONTROLLED RATE FREEZER
K032086 · Planer Plc · Mar 2004