Cleared Traditional

K000619 - SCANDINAVIAN IVF SCIENCES AB, G2.2

K000619 is an FDA 510(k) clearance for SCANDINAVIAN IVF SCIENCES AB, manufactured by Vitrolife AB/Scandinavian Ivf Sciences AB. The device is a Class 2 Obstetrics & Gynecology device with product code MQL cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K000619 · Vitrolife AB/Scandinavian Ivf Sciences AB · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2000
Decision
131d
Days
Class 2
Risk

K000619 is an FDA 510(k) clearance for the SCANDINAVIAN IVF SCIENCES AB, G2.2. Classified as Media, Reproductive (product code MQL), Class II - Special Controls.

Submitted by Vitrolife AB/Scandinavian Ivf Sciences AB (Washington, US). The FDA issued a Cleared decision on June 27, 2000 after a review of 131 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 Vitrolife AB/Scandinavian Ivf Sciences AB devices

FDA 510(k) Submission Details - K000619

510(k) Number K000619 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 2000
Decision Date June 27, 2000
Days to Decision 131 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 160d · This submission: 131d
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 214
Devices cleared under the same product code (MQL) and FDA review panel - the closest regulatory comparables to K000619.
COOK IVF FOLLICLE FLUSHING BUFFER, COOK IVF OOCYTE WASH BUFFER, COOK IVF FERTILIZATION MEDIUM, COOK IVF CLEAVAGE MEDIUM,
K002385 · Cook Ob/Gyn · Sep 2000
COOK IVF SPERM BUFFER, COOK IVF SPERM MEDIUM, AND COOK IVF SPERM GRADIENT KIT
K002383 · Cook Ob/Gyn · Sep 2000
MEDI-CULT UNIVERSAL IVF-MEDIUM
K991279 · Medicult A/S · Jul 2000
MEDI-CULT M3 MEDIUM
K991331 · Medicult A/S · Jun 2000
MEDI-CULT HYALURONIDASE
K991334 · Medicult A/S · Jun 2000
Q-HTF, CAT# 2001
K993484 · Invitrocare, Inc. · May 2000