Cleared Traditional

K081115 - G-MOPS G5 SERIES

K081115 is the FDA 510(k) clearance for G-MOPS G5 SERIES by Vitrolife Sweden AB. It is a Class 2 Obstetrics & Gynecology device (product code MQL) cleared through the Traditional 510(k) pathway after a 152-day FDA review.

K081115 · Vitrolife Sweden AB · Obstetrics & Gynecology device
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Sep 2008
Decision
152d
Days
Class 2
Risk

K081115 is an FDA 510(k) clearance for the G-MOPS G5 SERIES. Classified as Media, Reproductive (product code MQL), Class II - Special Controls.

Submitted by Vitrolife Sweden AB (Kungsbacka, SE). The FDA issued a Cleared decision on September 17, 2008 after a review of 152 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 Vitrolife Sweden AB devices

Submission Details

510(k) Number K081115 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 2008
Decision Date September 17, 2008
Days to Decision 152 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 160d · This submission: 152d
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 121
Devices cleared under the same product code (MQL) and FDA review panel - the closest regulatory comparables to K081115.
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RAPIDVIT AND RAPIDWARM CLEAVE
K080446 · Vitrolife Sweden AB · Nov 2008
G-1 V5
K081114 · Vitrolife Sweden AB · Sep 2008
G-2 V5
K081117 · Vitrolife Sweden AB · Sep 2008
G-IVF G5 SERIES
K081116 · Vitrolife Sweden AB · Sep 2008