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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
109d faster than avg
Panel avg: 161d · This submission: 52d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Obstetrics & Gynecology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT01138631 Completed Interventional

Selection of Embryos by Time-lapse

Selection of Embryos for IVF Treatment by Time-lapse

59
Patients (actual)
1
Site
Basic_science
Purpose
Open label
Masking
Condition studied Infertility
Study design Single group
Eligibility Female only
Principal investigator Jakob Ingerslev, DMSc
Sponsor University of Aarhus
Started 2010-06-01 → Primary completion 2010-12-01 → Completed 2011-05-01
Primary outcome
4-cell rate
Study completed - no results published. This trial concluded in 2011 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov

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 K111715.
XQ-1 INCUBATOR
K133742 · At Medical Uab · Apr 2014
PLANER BT37 INCUBATOR
K121566 · Planer Plc · Nov 2012
EMBRYO VIEWER SOFTWARE
K113075 · Unisense Fertilitech A/S · Dec 2011
HEAL FORCE CO2 INCUBATOR
K101988 · Shanghai Lishen Scientific Equipment Co., Ltd. · Feb 2011
EMBRYOSCOPE AND EMBRYOSLIDE
K092183 · Unisense Fertilitech A/S · Jan 2011
MINITUBE TEMPERATURE CONTROL UNIT SC-2000 + 2045
K050197 · Minitube of America, Inc. · Oct 2006