Cleared Traditional

K150961 - EmbryoSlide Culture Dish

K150961 is an FDA 510(k) clearance for EmbryoSlide Culture Dish, manufactured by Vitrolife A/S. The device is a Class 2 Obstetrics & Gynecology device with product code MQK cleared through the Traditional 510(k) pathway after a 238-day FDA review.

K150961 · Vitrolife A/S · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Dec 2015
Decision
238d
Days
Class 2
Risk

K150961 is an FDA 510(k) clearance for the EmbryoSlide Culture Dish. Classified as Labware, Assisted Reproduction (product code MQK), Class II - Special Controls.

Submitted by Vitrolife A/S (Viby J, DK). The FDA issued a Cleared decision on December 4, 2015 after a review of 238 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.6160 - 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 Vitrolife A/S devices

FDA 510(k) Submission Details - K150961

510(k) Number K150961 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 2015
Decision Date December 04, 2015
Days to Decision 238 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
78d slower than avg
Panel avg: 160d · This submission: 238d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQK Device Classification - Class 2, Special Controls

Product Code MQK Labware, Assisted Reproduction
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.6160
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 - MQK Labware, Assisted Reproduction

All 21
Devices cleared under the same product code (MQK) and FDA review panel - the closest regulatory comparables to K150961.
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