Cleared Traditional

K000623 - SCANDINAVIAN IVF SCIENCES AB, FREEZE-KIT 1

K000623 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 89-day FDA review.

K000623 · 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
May 2000
Decision
89d
Days
Class 2
Risk

K000623 is an FDA 510(k) clearance for the SCANDINAVIAN IVF SCIENCES AB, FREEZE-KIT 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 May 16, 2000 after a review of 89 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.

FDA 510(k) Submission Details - K000623

510(k) Number K000623 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 2000
Decision Date May 16, 2000
Days to Decision 89 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
72d faster than avg
Panel avg: 161d · This submission: 89d
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 K000623.
SCANDINAVIAN IVF SCIENCES AB, THAW-KIT 1
K000618 · Vitrolife AB/Scandinavian Ivf Sciences AB · May 2000
IVF 20, IVF 50, IVF 500, IVF 500 ANTIBIOTIC FREE, MODELS 2420, 2004, 2501, 2500
K991348 · Vitrolife Sweden AB · May 2000
SCANDINAVIAN IVF SCIENCES AB, SPERMRINSE -20/100
K000621 · Vitrolife AB/Scandinavian Ivf Sciences AB · May 2000
MEDI-CULT BLASTOCYST FREEZING & THAWING PACKS, INTERNAL CATALOG NUMBERS (1012, 1015)
K991471 · Medicult A/S · May 2000
MEDI-CULT EMBRYO FREEZING MEDIUM INTERNAL CATAGLOG NUMBERS 1079
K991472 · Medicult A/S · May 2000
HTF-HEPES
K000939 · Invitrocare, Inc. · May 2000
K000623 · SCANDINAVIAN IVF SCIENCES AB, FREEZE-KIT 1
Download PDF FDA Summary Vitrolife AB/Scandina…