Cleared Traditional

K233177 - Nest VT Vitrification Device

K233177 is the FDA 510(k) clearance for Nest VT Vitrification Device by Cook Incorporated. It is a Class 2 Obstetrics & Gynecology device (product code MQK) cleared through the Traditional 510(k) pathway after a 162-day FDA review.

K233177 · Cook Incorporated · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2024
Decision
162d
Days
Class 2
Risk

K233177 is an FDA 510(k) clearance for the Nest VT Vitrification Device. Classified as Labware, Assisted Reproduction (product code MQK), Class II - Special Controls.

Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on March 8, 2024 after a review of 162 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 Cook Incorporated devices

Submission Details

510(k) Number K233177 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2023
Decision Date March 08, 2024
Days to Decision 162 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
2d slower than avg
Panel avg: 160d · This submission: 162d
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 18
Devices cleared under the same product code (MQK) and FDA review panel - the closest regulatory comparables to K233177.
cryo-GO Vitrification Device
K241341 · Fujifilm Irvine Scientific · Sep 2024
G-Vitri™ Vitrification Straw
K240002 · Gimbo Medical Technology Shenzhen Co., Ltd. · Jun 2024
SpermAlign Sperm Separation Device
K232980 · Cytoswim, Ltd. · Mar 2024
LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation Device
K221810 · Bonraybio Co., Ltd. · Oct 2022
EmbryoSlide+ ic8 dish
K213869 · Vitrolife A/S · Mar 2022
SureStrip Vitrification Straw, SureLock Vitrification Straw
K203626 · Allwin Medical Devices, Inc. · Jun 2021