Cleared Traditional

K080473 - EMBRYOASSIST AND EMBRYOASSIST WITH PHEN...

K080473 is an FDA 510(k) clearance for EMBRYOASSIST AND EMBRYOASSIST WITH PHEN..., manufactured by Medicult A/S. The device is a Class 2 Obstetrics & Gynecology device with product code MQL cleared through the Traditional 510(k) pathway after a 195-day FDA review.

K080473 · Medicult A/S · Obstetrics & Gynecology device
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Sep 2008
Decision
195d
Days
Class 2
Risk

K080473 is an FDA 510(k) clearance for the EMBRYOASSIST AND EMBRYOASSIST WITH PHENOL RED. Classified as Media, Reproductive (product code MQL), Class II - Special Controls.

Submitted by Medicult A/S (San Diego, US). The FDA issued a Cleared decision on September 3, 2008 after a review of 195 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 Medicult A/S devices

FDA 510(k) Submission Details - K080473

510(k) Number K080473 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 2008
Decision Date September 03, 2008
Days to Decision 195 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
35d slower than avg
Panel avg: 160d · This submission: 195d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQL Device Classification - Class 2, Special Controls

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 167
Devices cleared under the same product code (MQL) and FDA review panel - the closest regulatory comparables to K080473.
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K081116 · Vitrolife Sweden AB · Sep 2008
SINGLE STEP MEDIUM
K072609 · Irvine Scientific Sales Co., Inc. · Feb 2008
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K072608 · Irvine Scientific Sales Co., Inc. · Jan 2008