Cleared Traditional

K150756 - Micro well group culture dish, 9-well

Also marketed or referenced as:
Micro well group culture dish, 16-well

K150756 is an FDA 510(k) clearance for Micro well group culture dish, manufactured by Hertart. The device is a Class 2 Obstetrics & Gynecology device with product code MQK cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K150756 · Hertart · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2015
Decision
119d
Days
Class 2
Risk

K150756 is an FDA 510(k) clearance for the Micro well group culture dish, 9-well. Classified as Labware, Assisted Reproduction (product code MQK), Class II - Special Controls.

Submitted by Hertart (Västra Frölunda, SE). The FDA issued a Cleared decision on July 20, 2015 after a review of 119 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K150756

510(k) Number K150756 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 2015
Decision Date July 20, 2015
Days to Decision 119 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
42d faster than avg
Panel avg: 161d · This submission: 119d
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 Consultant

Hertart Aps
Goran Mellbin

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MQK Labware, Assisted Reproduction

All 49
Devices cleared under the same product code (MQK) and FDA review panel - the closest regulatory comparables to K150756.
Cryotec
K162051 · Reprolife, Inc. · Dec 2016
Cryotop US
K153027 · Kitazato Biopharma Co;Ltd · Mar 2016
EmbryoSlide Culture Dish
K150961 · Vitrolife A/S · Dec 2015
RAPID-I KIT
K140207 · Vitrolife Sweden AB · Dec 2014
EEVA DISH (WITH 12 MICROWELLS)
K141663 · Auxogyn, Inc. · Jul 2014
QUALIS
K133295 · Menicon Co., Ltd. New Business Division · Jun 2014