Cleared Traditional

K061309 - EMBRYOASSIST

K061309 is an FDA 510(k) clearance for EMBRYOASSIST, 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 274-day FDA review.

K061309 · Medicult A/S · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2007
Decision
274d
Days
Class 2
Risk

K061309 is an FDA 510(k) clearance for the EMBRYOASSIST. 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 February 8, 2007 after a review of 274 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 - K061309

510(k) Number K061309 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 2006
Decision Date February 08, 2007
Days to Decision 274 days
Submission Type Traditional
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
114d slower than avg
Panel avg: 160d · This submission: 274d
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 K061309.
LYOPHILIZED MULTIBLAST MEDIUM KIT
K072608 · Irvine Scientific Sales Co., Inc. · Jan 2008
LYOPHILIZED EARLY CLEAVAGE MEDIUM (ECM) KIT
K072607 · Irvine Scientific Sales Co., Inc. · Jan 2008
LG SPERM FREEZING
K070689 · Intl., Inc. · Jul 2007
SPERMSLOW
K061145 · Medicult A/S · Oct 2006
SYDNEY IVF SPERM CRYOPRESERVATION BUFFER
K061371 · Cook Urological, Inc. · Aug 2006
BIOPSY MEDIUM, MODEL REF 1062
K060983 · Medicult A/S · Jul 2006