Cleared Special

K180740 - VitriGuard

K180740 is an FDA 510(k) clearance for VitriGuard, manufactured by Origio A/S. The device is a Class 2 Obstetrics & Gynecology device with product code MQK cleared through the Special 510(k) pathway after a 43-day FDA review.

K180740 · Origio A/S · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2018
Decision
43d
Days
Class 2
Risk

K180740 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 May 4, 2018 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.6160 - the FDA obstetrics and gynecology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K180740

510(k) Number K180740 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 2018
Decision Date May 04, 2018
Days to Decision 43 days
Submission Type Special
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
118d faster than avg
Panel avg: 161d · This submission: 43d
Pathway characteristics
Modification to existing cleared device.

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.

Regulatory Consultant

CooperSurgical, Inc.
Roaida Johnson

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 - MQK Labware, Assisted Reproduction

All 52
Devices cleared under the same product code (MQK) and FDA review panel - the closest regulatory comparables to K180740.
VitriGuard
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iVitri EZ
K162640 · Reprobitech Corp. · Jun 2017
K180740 · VitriGuard
Download PDF FDA Summary Origio A/S