Cleared Traditional

K031015 - EMBRYOGLUE

K031015 is the FDA 510(k) clearance for EMBRYOGLUE by Vitrolife Sweden AB. It is a Class 2 Obstetrics & Gynecology device (product code MQL) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K031015 · Vitrolife Sweden AB · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2003
Decision
84d
Days
Class 2
Risk

K031015 is an FDA 510(k) clearance for the EMBRYOGLUE. Classified as Media, Reproductive (product code MQL), Class II - Special Controls.

Submitted by Vitrolife Sweden AB (Gothenberg, SE). The FDA issued a Cleared decision on June 23, 2003 after a review of 84 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Vitrolife Sweden AB devices

Submission Details

510(k) Number K031015 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2003
Decision Date June 23, 2003
Days to Decision 84 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
76d faster than avg
Panel avg: 160d · This submission: 84d
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 121
Devices cleared under the same product code (MQL) and FDA review panel - the closest regulatory comparables to K031015.
EARLY CLEAVAGE MEDIUM (ECM)
K033462 · Irvine Scientific Sales Co., Inc. · Jan 2004
PHENOL RED STOCK SOLUTION
K032887 · Irvine Scientific Sales Co., Inc. · Dec 2003
SYDNEY IVF BLASTOCYST CRYOPRESERVATION KIT AND SYDNEY IVF BLASTOCYST THAW KIT
K030441 · Cook Ob/Gyn · Aug 2003
SYDNEY IVF EMBRYO BIOPSY MEDIUM
K023850 · Cook Ob/Gyn · Jan 2003
SYDNEY IVF HYALURONIDASE
K023353 · Cook Urological, Inc. · Dec 2002
SPERMGRAD, MODELS 10022/10063
K023403 · Vitrolife Sweden AB · Dec 2002