Cleared Traditional

K090429 - NUNC IVF CENTERWELL AND ICSI DISHES (FDA 510(k) Clearance)

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K090429 · Thermo Fisher Scientific (Nalge Nunc Intl) · Obstetrics & Gynecology device
Download Printable Device Report (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.

View all Thermo Fisher Scientific (Nalge Nunc Intl) devices

Submission Details

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
Regulatory Context
Review time vs. panel average
51d slower than avg
Panel avg: 160d · This submission: 211d
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 Peers - MQK Labware, Assisted Reproduction

All 49
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