Cleared Traditional

K090429 - NUNC IVF CENTERWELL AND ICSI DISHES

K090429 is an FDA 510(k) clearance for NUNC IVF CENTERWELL AND ICSI DISHES, manufactured by Thermo Fisher Scientific (Nalge Nunc Intl). The device is a Class 2 Obstetrics & Gynecology device with product code MQK cleared through the Traditional 510(k) pathway after a 211-day FDA review.

K090429 · Thermo Fisher Scientific (Nalge Nunc Intl) · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2009
Decision
211d
Days
Class 2
Risk

K090429 is an FDA 510(k) clearance for the NUNC IVF CENTERWELL AND ICSI DISHES. Classified as Labware, Assisted Reproduction (product code MQK), Class II - Special Controls.

Submitted by Thermo Fisher Scientific (Nalge Nunc Intl) (Rochester, US). The FDA issued a Cleared decision on September 18, 2009 after a review of 211 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 - K090429

510(k) Number K090429 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 2009
Decision Date September 18, 2009
Days to Decision 211 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
50d slower than avg
Panel avg: 161d · This submission: 211d
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 52
Devices cleared under the same product code (MQK) and FDA review panel - the closest regulatory comparables to K090429.
CRYOPETTE
K100596 · Mid-Atlantic Diagnostics, Inc. · Dec 2010
HSV STRAW
K092398 · Cryo Bio System · Oct 2010
RAPID-I
K090832 · Vitrolife Sweden AB · Dec 2009
BIOGENICS BIOQUAD 4-WELL IVF CULTURE DISH
K081896 · Biogenics, Inc. · Aug 2008
SUNIVF DISHES
K080395 · Intl., Inc. · Aug 2008
NUNC IVF DISHES AND NUNC IVF 4-WELL DISH
K070047 · Nunc A/S · May 2007
K090429 · NUNC IVF CENTERWELL AND ICSI DISHES
Download PDF FDA Summary Thermo Fisher Scienti…