Cleared Traditional

K113786 - SPERMFREEZE SOLUTION

K113786 is an FDA 510(k) clearance for SPERMFREEZE SOLUTION, manufactured by Vitrolife Sweden AB. The device is a Class 2 Obstetrics & Gynecology device with product code MQL cleared through the Traditional 510(k) pathway after a 309-day FDA review.

K113786 · Vitrolife Sweden AB · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2012
Decision
309d
Days
Class 2
Risk

K113786 is an FDA 510(k) clearance for the SPERMFREEZE SOLUTION. Classified as Media, Reproductive (product code MQL), Class II - Special Controls.

Submitted by Vitrolife Sweden AB (Gutengurg, SE). The FDA issued a Cleared decision on October 26, 2012 after a review of 309 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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

FDA 510(k) Submission Details - K113786

510(k) Number K113786 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2011
Decision Date October 26, 2012
Days to Decision 309 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
149d slower than avg
Panel avg: 160d · This submission: 309d
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 213
Devices cleared under the same product code (MQL) and FDA review panel - the closest regulatory comparables to K113786.
ORIGIO SEQUENTIAL FERT, ORIGIO SEQUENTIAL FERT WITH PHENOL RED, ORIGIO SEQUENTIAL CLEAV, ORIGIO SEQUENTIAL CLEAV, ORIGIO
K133912 · Origio A/S · May 2014
ORIGIO(R) SEQUENTIAL BLAST TM
K133387 · Origio A/S · Apr 2014
SAGE 1-STEP WITH HUMAN SERUM ALBUMIN, SAGE 1-STEP WITH SERUM PROTEIN SUPPLEMENTS
K133707 · Origio A/S · Apr 2014
EMBRYOGEN
K120136 · Origio A/S · Sep 2012
CONTINUOUS SINGLE CULTURE COMPLETE
K121572 · Irvine Scientific Sales Co., Inc. · Jul 2012
MULTIPURPOSE HANDLING MEDIUM
K121128 · Irvine Scientific Sales Co., Inc. · Jun 2012