Cleared Traditional

K160864 - Cryotop Vitrification Kit and Cryotop Thawing Kit

K160864 is an FDA 510(k) clearance for Cryotop Vitrification Kit and Cryotop T..., manufactured by Kitazato Biopharma Co;Ltd. The device is a Class 2 Obstetrics & Gynecology device with product code MQL cleared through the Traditional 510(k) pathway after a 192-day FDA review.

K160864 · Kitazato Biopharma Co;Ltd · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2016
Decision
192d
Days
Class 2
Risk

K160864 is an FDA 510(k) clearance for the Cryotop Vitrification Kit and Cryotop Thawing Kit. Classified as Media, Reproductive (product code MQL), Class II - Special Controls.

Submitted by Kitazato Biopharma Co;Ltd (Fuji, JP). The FDA issued a Cleared decision on October 7, 2016 after a review of 192 days - an extended review cycle.

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 - K160864

510(k) Number K160864 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 2016
Decision Date October 07, 2016
Days to Decision 192 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d slower than avg
Panel avg: 161d · This submission: 192d
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 Consultant

Emergo Global Consulting, LLC
RICHARD VINCINS

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 - MQL Media, Reproductive

All 259
Devices cleared under the same product code (MQL) and FDA review panel - the closest regulatory comparables to K160864.
Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blastocyst Medium, Gems VitBase
K161261 · Genea Biomedx Pty, Ltd. · May 2017
SAGE Vitrification Kit and SAGE Vitrification Warming Kit
K170560 · CooperSurgical, Inc. · Apr 2017
Sydney IVF Culture Oil
K170257 · William A. Cook Australia Pty. , Ltd. · Feb 2017
Sydney IVF Gamete Buffer
K153478 · William A. Cook Australia Pty. , Ltd. · Aug 2016
PBS(-), Phosphate Buffered Saline
K160863 · Kitazato Biopharma Co;Ltd · Jul 2016
ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm Wash
K153267 · Origio A/S · Jul 2016