Cleared Traditional

K080395 - SUNIVF DISHES

K080395 is an FDA 510(k) clearance for SUNIVF DISHES, manufactured by Intl., Inc.. The device is a Class 2 Obstetrics & Gynecology device with 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.

FDA 510(k) Submission Details - K080395

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
21d slower than avg
Panel avg: 161d · This submission: 182d
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

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.

Regulatory Peers - MQK Labware, Assisted Reproduction

All 52
Devices cleared under the same product code (MQK) and FDA review panel - the closest regulatory comparables to K080395.
RAPID-I
K090832 · Vitrolife Sweden AB · Dec 2009
NUNC IVF CENTERWELL AND ICSI DISHES
K090429 · Thermo Fisher Scientific (Nalge Nunc Intl) · Sep 2009
BIOGENICS BIOQUAD 4-WELL IVF CULTURE DISH
K081896 · Biogenics, Inc. · Aug 2008
NUNC IVF DISHES AND NUNC IVF 4-WELL DISH
K070047 · Nunc A/S · May 2007
PICSI SPERM SELECTION DEVICE
K052457 · Biocoat, Inc. · Apr 2006
NUNC IVF MULTIDISH 4 WELLS NUNCLON
K040717 · Nunc A/S · Aug 2004
K080395 · SUNIVF DISHES
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