Cleared Traditional

K100367 - MEDICULT VITRIFICATION COOLING/WARMING

K100367 is the FDA 510(k) clearance for MEDICULT VITRIFICATION COOLING/WARMING by Origio A/S. It is a Class 2 Obstetrics & Gynecology device (product code MQL) cleared through the Traditional 510(k) pathway after a 196-day FDA review.

K100367 · Origio A/S · Obstetrics & Gynecology device
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Aug 2010
Decision
196d
Days
Class 2
Risk

K100367 is an FDA 510(k) clearance for the MEDICULT VITRIFICATION COOLING/WARMING, MODEL REF: 1228, 1229. Classified as Media, Reproductive (product code MQL), Class II - Special Controls.

Submitted by Origio A/S (San Diego, US). The FDA issued a Cleared decision on August 27, 2010 after a review of 196 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.

View all Origio A/S devices

Submission Details

510(k) Number K100367 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 2010
Decision Date August 27, 2010
Days to Decision 196 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
36d slower than avg
Panel avg: 160d · This submission: 196d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Peers - MQL Media, Reproductive

All 122
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