Cleared Traditional

K080395 - SUNIVF DISHES

K080395 is the FDA 510(k) clearance for SUNIVF DISHES by Intl., Inc.. It is a Class 2 Obstetrics & Gynecology device (product code MQK) cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K080395 · Intl., Inc. · Obstetrics & Gynecology device
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Aug 2008
Decision
182d
Days
Class 2
Risk

K080395 is an FDA 510(k) clearance for the SUNIVF DISHES. Classified as Labware, Assisted Reproduction (product code MQK), Class II - Special Controls.

Submitted by <Genx> Intl., Inc. (Gilford, US). The FDA issued a Cleared decision on August 13, 2008 after a review of 182 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 Intl., Inc. devices

Submission Details

510(k) Number K080395 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 2008
Decision Date August 13, 2008
Days to Decision 182 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d slower than avg
Panel avg: 160d · This submission: 182d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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

Intl., Inc.
MICHAEL D CECCHI

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.