Cleared Traditional

K111715 - EMBRYOSCOPE

K111715 is an FDA 510(k) clearance for EMBRYOSCOPE, 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 52-day FDA review.

K111715 · Unisense Fertilitech A/S · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2011
Decision
52d
Days
Class 2
Risk

K111715 is an FDA 510(k) clearance for the EMBRYOSCOPE. Classified as Accessory, Assisted Reproduction (product code MQG), Class II - Special Controls.

Submitted by Unisense Fertilitech A/S (Arrhus N, DK). The FDA issued a Cleared decision on August 11, 2011 after a review of 52 days - a notably fast clearance cycle.

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: 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 Unisense Fertilitech A/S devices

FDA 510(k) Submission Details - K111715

510(k) Number K111715 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 2011
Decision Date August 11, 2011
Days to Decision 52 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
108d faster than avg
Panel avg: 160d · This submission: 52d
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 14
Devices cleared under the same product code (MQG) and FDA review panel - the closest regulatory comparables to K111715.
Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish
K180188 · Genea Biomedx Pty, Ltd. · Jun 2018
EmbryoScope+
K173264 · Vitrolife A/S · May 2018
Geri Embryo Incubator and Geri Dish
K180304 · Genea Biomedx Pty, Ltd. · Apr 2018
WORKBENCH BY
K020560 · Intl., Inc. · Jun 2002
PGD-PRE-IMPLANTATION GENETIC DIAGNOSTIC PIPETTES (BIOPSY PIPETTES)
K014160 · Cook Urological, Inc. · Feb 2002
CODA INCUBATOR CELLMATE
K001600 · Intl., Inc. · Nov 2000