Cleared Traditional

K070689 - LG SPERM FREEZING

K070689 is the FDA 510(k) clearance for LG SPERM FREEZING by Intl., Inc.. It is a Class 2 Obstetrics & Gynecology device (product code MQL) cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K070689 · Intl., Inc. · Obstetrics & Gynecology device
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Jul 2007
Decision
112d
Days
Class 2
Risk

K070689 is an FDA 510(k) clearance for the LG SPERM FREEZING. Classified as Media, Reproductive (product code MQL), Class II - Special Controls.

Submitted by <Genx> Intl., Inc. (Gilford, US). The FDA issued a Cleared decision on July 3, 2007 after a review of 112 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 Intl., Inc. devices

Submission Details

510(k) Number K070689 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 2007
Decision Date July 03, 2007
Days to Decision 112 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 160d · This submission: 112d
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 141
Devices cleared under the same product code (MQL) and FDA review panel - the closest regulatory comparables to K070689.
SINGLE STEP MEDIUM
K072609 · Irvine Scientific Sales Co., Inc. · Feb 2008
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
SYDNEY IVF SPERM CRYOPRESERVATION BUFFER
K061371 · Cook Urological, Inc. · Aug 2006
GLOBAL FERTILIZATION, EMBRYO CULTURE AND TRANSFER MEDIA
K053552 · Intl., Inc. · May 2006
MICROMANIPULATION MEDIA SYSTEM, LG HYALURONIDASE AND LG PARAFFIN OIL
K053551 · Intl., Inc. · May 2006