Cleared Traditional

K070047 - NUNC IVF DISHES AND NUNC IVF 4-WELL DISH

K070047 is an FDA 510(k) clearance for NUNC IVF DISHES AND NUNC IVF 4-WELL DISH, manufactured by Nunc A/S. The device is a Class 2 Obstetrics & Gynecology device with product code MQK cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K070047 · Nunc A/S · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2007
Decision
134d
Days
Class 2
Risk

K070047 is an FDA 510(k) clearance for the NUNC IVF DISHES AND NUNC IVF 4-WELL DISH. Classified as Labware, Assisted Reproduction (product code MQK), Class II - Special Controls.

Submitted by Nunc A/S (Roskilde, DK). The FDA issued a Cleared decision on May 18, 2007 after a review of 134 days - within the typical 510(k) review window.

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 - K070047

510(k) Number K070047 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 2007
Decision Date May 18, 2007
Days to Decision 134 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
27d faster than avg
Panel avg: 161d · This submission: 134d
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 49
Devices cleared under the same product code (MQK) and FDA review panel - the closest regulatory comparables to K070047.
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
SUNIVF DISHES
K080395 · Intl., Inc. · Aug 2008
PICSI SPERM SELECTION DEVICE
K052457 · Biocoat, Inc. · Apr 2006
NUNC IVF MULTIDISH 4 WELLS NUNCLON
K040717 · Nunc A/S · Aug 2004
PASTEUR PIPET - STERILE 9, PASTEUR PIPET - STERILE 5 3/4, MODELS 16-PP-9, 16-PP-5.75
K000915 · Humagen Fertility Diagnostics, Inc. · May 2000
K070047 · NUNC IVF DISHES AND NUNC IVF 4-WELL DISH
Download PDF FDA Summary Nunc A/S