Cleared Traditional

K081639 - ICSI CUMULASE

K081639 is an FDA 510(k) clearance for ICSI CUMULASE, 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 100-day FDA review.

K081639 · Medicult A/S · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2008
Decision
100d
Days
Class 2
Risk

K081639 is an FDA 510(k) clearance for the ICSI CUMULASE. 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 19, 2008 after a review of 100 days - within the typical 510(k) review window.

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 - K081639

510(k) Number K081639 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 2008
Decision Date September 19, 2008
Days to Decision 100 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
60d faster than avg
Panel avg: 160d · This submission: 100d
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 K081639.
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G-1 V5
K081114 · Vitrolife Sweden AB · Sep 2008
G-2 V5
K081117 · Vitrolife Sweden AB · Sep 2008