Cleared Traditional

K081896 - BIOGENICS BIOQUAD 4-WELL IVF CULTURE DISH

K081896 is an FDA 510(k) clearance for BIOGENICS BIOQUAD 4-WELL IVF CULTURE DISH, manufactured by Biogenics, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code MQK cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K081896 · Biogenics, Inc. · Obstetrics & Gynecology device
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Aug 2008
Decision
48d
Days
Class 2
Risk

K081896 is an FDA 510(k) clearance for the BIOGENICS BIOQUAD 4-WELL IVF CULTURE DISH. Classified as Labware, Assisted Reproduction (product code MQK), Class II - Special Controls.

Submitted by Biogenics, Inc. (Napa, US). The FDA issued a Cleared decision on August 20, 2008 after a review of 48 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K081896

510(k) Number K081896 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2008
Decision Date August 20, 2008
Days to Decision 48 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
113d faster than avg
Panel avg: 161d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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

Intertek Testing Services
DANIEL W LEHTONEN

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 K081896.
HSV STRAW
K092398 · Cryo Bio System · Oct 2010
RAPID-I
K090832 · Vitrolife Sweden AB · Dec 2009
NUNC IVF CENTERWELL AND ICSI DISHES
K090429 · Thermo Fisher Scientific (Nalge Nunc Intl) · Sep 2009
SUNIVF DISHES
K080395 · Intl., 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

FDA 510(k) Resources - Obstetrics & Gynecology

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

K081896 · BIOGENICS BIOQUAD 4-WELL IVF CULTURE DISH
Download PDF Biogenics, Inc.