Cleared Traditional

K120136 - EMBRYOGEN

K120136 is an FDA 510(k) clearance for EMBRYOGEN, manufactured by Origio A/S. The device is a Class 2 Obstetrics & Gynecology device with product code MQL cleared through the Traditional 510(k) pathway after a 253-day FDA review.

K120136 · Origio A/S · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2012
Decision
253d
Days
Class 2
Risk

K120136 is an FDA 510(k) clearance for the EMBRYOGEN. Classified as Media, Reproductive (product code MQL), Class II - Special Controls.

Submitted by Origio A/S (Poway, US). The FDA issued a Cleared decision on September 26, 2012 after a review of 253 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.6180 - 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 Origio A/S devices

FDA 510(k) Submission Details - K120136

510(k) Number K120136 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 2012
Decision Date September 26, 2012
Days to Decision 253 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
93d slower than avg
Panel avg: 160d · This submission: 253d
Pathway characteristics
Predicate-based equivalence.

MQL Device Classification - Class 2, Special Controls

Product Code MQL Media, Reproductive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.6180
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
NCT00565747 Completed Interventional Industry-sponsored

Efficacy Study of Granulocyte-macrophage Colony Stimulating Factor (GM-CSF) for Use in Human IVF

The Effect of Granulocyte-macrophage Colony Stimulating Factor (GM-CSF) During in Vitro Culture of Human Embryos on Subsequent Implantation Rates.

1332
Patients (actual)
14
Sites
Treatment
Purpose
Quadruple
Masking
Condition studied Infertility
Study design Parallel
Eligibility Female only · 25 Years+
Principal investigator Søren Ziebe, M.Sc.
Sponsor Origio A/S (industry)
Started 2007-11-01 → Primary completion 2010-11-01 → Completed 2011-09-01
Primary outcome
Ongoing Implantation Rate Week 7
Secondary outcome
Number of Top Quality Embryos (TQE´s)
View full study on ClinicalTrials.gov

Regulatory Peers - MQL Media, Reproductive

All 213
Devices cleared under the same product code (MQL) and FDA review panel - the closest regulatory comparables to K120136.
ORIGIO(R) SEQUENTIAL BLAST TM
K133387 · Origio A/S · Apr 2014
SAGE 1-STEP WITH HUMAN SERUM ALBUMIN, SAGE 1-STEP WITH SERUM PROTEIN SUPPLEMENTS
K133707 · Origio A/S · Apr 2014
SPERMFREEZE SOLUTION
K113786 · Vitrolife Sweden AB · Oct 2012
CONTINUOUS SINGLE CULTURE COMPLETE
K121572 · Irvine Scientific Sales Co., Inc. · Jul 2012
MULTIPURPOSE HANDLING MEDIUM
K121128 · Irvine Scientific Sales Co., Inc. · Jun 2012
LIFEGLOBAL TOTAL, TOTAL FOR FERTILIZATION, TOTAL W/HEPES, HTF TOTAL, HTF TOTAL W/HEPES
K112083 · Intl., Inc. · May 2012