Cleared Traditional

K162833 - VitriGuard

K162833 is the FDA 510(k) clearance for VitriGuard by Origio A/S. It is a Class 2 Obstetrics & Gynecology device (product code MQK) cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K162833 · Origio A/S · Obstetrics & Gynecology device
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Feb 2017
Decision
128d
Days
Class 2
Risk

K162833 is an FDA 510(k) clearance for the VitriGuard. Classified as Labware, Assisted Reproduction (product code MQK), Class II - Special Controls.

Submitted by Origio A/S (Måløv, DK). The FDA issued a Cleared decision on February 16, 2017 after a review of 128 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.

View all Origio A/S devices

Submission Details

510(k) Number K162833 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 2016
Decision Date February 16, 2017
Days to Decision 128 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 160d · This submission: 128d
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 19
Devices cleared under the same product code (MQK) and FDA review panel - the closest regulatory comparables to K162833.
VitriGuard
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K172751 · Reprobitech Corp. · Feb 2018
RAPID-I KIT
K140207 · Vitrolife Sweden AB · Dec 2014
RAPID-I
K090832 · Vitrolife Sweden AB · Dec 2009