Cleared Traditional

K133712 - EMBRYOVIEWER SOFTWARE

K133712 is an FDA 510(k) clearance for EMBRYOVIEWER SOFTWARE, 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 246-day FDA review.

K133712 · 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 2014
Decision
246d
Days
Class 2
Risk

K133712 is an FDA 510(k) clearance for the EMBRYOVIEWER SOFTWARE. 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 8, 2014 after a review of 246 days - an extended review 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: 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.

FDA 510(k) Submission Details - K133712

510(k) Number K133712 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 2013
Decision Date August 08, 2014
Days to Decision 246 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
85d slower than avg
Panel avg: 161d · This submission: 246d
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
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