Cleared Traditional

K160006 - Vit Kit-Freeze Oocytes, Embryos and PN zygotes Vitrification Freeze Kit, Vit Kit-Thaw Oocytes, Embryos and PN zygotes Vitrification Thaw Kit

K160006 is an FDA 510(k) clearance for Vit Kit-Freeze Oocytes, manufactured by Irvine Scientific. The device is a Class 2 Obstetrics & Gynecology device with product code MQL cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K160006 · Irvine Scientific · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2016
Decision
121d
Days
Class 2
Risk

K160006 is an FDA 510(k) clearance for the Vit Kit-Freeze Oocytes, Embryos and PN zygotes Vitrification Freeze Kit, Vit .... Classified as Media, Reproductive (product code MQL), Class II - Special Controls.

Submitted by Irvine Scientific (Santa Ana, US). The FDA issued a Cleared decision on May 4, 2016 after a review of 121 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.6180 - 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 - K160006

510(k) Number K160006 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 2016
Decision Date May 04, 2016
Days to Decision 121 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
40d faster than avg
Panel avg: 161d · This submission: 121d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQL Device Classification - Class 2, Special Controls

Product Code MQL Media, Reproductive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.6180
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 - MQL Media, Reproductive

All 259
Devices cleared under the same product code (MQL) and FDA review panel - the closest regulatory comparables to K160006.
ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm Wash
K153267 · Origio A/S · Jul 2016
Sydney IVF Blastocyst Cryopreservation Kit, Sydney IVF Blastocyst Thawing Kit
K152717 · William A. Cook Australia Pty. , Ltd. · May 2016
Sydney IVF Cryopreservation Kit, Sydney IVF Thawing Kit
K152682 · Willian A. Cook Australia Pty, Ltd. · May 2016
Sydney IVF Sperm Cryopreservation Buffer
K160814 · William A. Cook Australia Pty. , Ltd. · Apr 2016
MINERAL OIL
K160142 · Kitazato Biopharma Co;Ltd · Apr 2016
BlastGen
K152932 · Origio A/S · Feb 2016
K160006 · Vit Kit-Freeze Oocytes, Embryos and PN zygotes Vitrification Freeze Kit, Vit Kit-Thaw Oocytes, Embryos and PN zygotes Vitrification Thaw Kit
Download PDF FDA Summary Irvine Scientific