Cleared Abbreviated

K173075 - ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device (850µl, 3ml)

K173075 is an FDA 510(k) clearance for ZyMot ICSI Sperm Separation Device, manufactured by Dxnow, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code MQK cleared through the Abbreviated 510(k) pathway after a 160-day FDA review.

K173075 · Dxnow, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2018
Decision
160d
Days
Class 2
Risk

K173075 is an FDA 510(k) clearance for the ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device (850µ.... Classified as Labware, Assisted Reproduction (product code MQK), Class II - Special Controls.

Submitted by Dxnow, Inc. (Gaithersburg, US). The FDA issued a Cleared decision on March 8, 2018 after a review of 160 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Dxnow, Inc. devices

FDA 510(k) Submission Details - K173075

510(k) Number K173075 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2017
Decision Date March 08, 2018
Days to Decision 160 days
Submission Type Abbreviated
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
At panel average
Panel avg: 160d · This submission: 160d
Pathway characteristics
Standards-based clearance path.

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.

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