Cleared Traditional

K000627 - SCANDINAVIAN IVF SCIENCES AB, HYBASE-1

K000627 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 117-day FDA review.

K000627 · Vitrolife AB/Scandinavian Ivf Sciences AB · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2000
Decision
117d
Days
Class 2
Risk

K000627 is an FDA 510(k) clearance for the SCANDINAVIAN IVF SCIENCES AB, HYBASE-1. 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 13, 2000 after a review of 117 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.

FDA 510(k) Submission Details - K000627

510(k) Number K000627 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 2000
Decision Date June 13, 2000
Days to Decision 117 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
44d faster than avg
Panel avg: 161d · This submission: 117d
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 259
Devices cleared under the same product code (MQL) and FDA review panel - the closest regulatory comparables to K000627.
SCANDINAVIAN IVF SCIENCES AB, G2.2
K000619 · Vitrolife AB/Scandinavian Ivf Sciences AB · Jun 2000
MEDI-CULT M3 MEDIUM
K991331 · Medicult A/S · Jun 2000
MEDI-CULT HYALURONIDASE
K991334 · Medicult A/S · Jun 2000
IVC THREE BLASTOCYST MEDIUM, CAT # 2007
K001113 · Invitrocare, Inc. · Jun 2000
SPERM WASH MEDIUM, CAT# 2003/2005
K000989 · Invitrocare, Inc. · Jun 2000
IVC TWO MEDIUM
K000937 · Invitrocare, Inc. · May 2000
K000627 · SCANDINAVIAN IVF SCIENCES AB, HYBASE-1
Download PDF FDA Summary Vitrolife AB/Scandina…