Cleared Traditional

K133295 - QUALIS

K133295 is an FDA 510(k) clearance for QUALIS, manufactured by Menicon Co., Ltd. New Business Division. The device is a Class 2 Obstetrics & Gynecology device with product code MQK cleared through the Traditional 510(k) pathway after a 236-day FDA review.

K133295 · Menicon Co., Ltd. New Business Division · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2014
Decision
236d
Days
Class 2
Risk

K133295 is an FDA 510(k) clearance for the QUALIS. Classified as Labware, Assisted Reproduction (product code MQK), Class II - Special Controls.

Submitted by Menicon Co., Ltd. New Business Division (Minneapolis, US). The FDA issued a Cleared decision on June 18, 2014 after a review of 236 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.

FDA 510(k) Submission Details - K133295

510(k) Number K133295 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 2013
Decision Date June 18, 2014
Days to Decision 236 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
75d slower than avg
Panel avg: 161d · This submission: 236d
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 49
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