Cleared Traditional

K991348 - IVF 20, IVF 50, IVF 500, IVF 500 ANTIBIOTIC FREE, MODELS 2420, 2004, 2501, 2500

K991348 is an FDA 510(k) clearance for IVF 20, 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 394-day FDA review.

K991348 · Vitrolife Sweden 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
394d
Days
Class 2
Risk

K991348 is an FDA 510(k) clearance for the IVF 20, IVF 50, IVF 500, IVF 500 ANTIBIOTIC FREE, MODELS 2420, 2004, 2501, 2500. 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 May 17, 2000 after a review of 394 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.

FDA 510(k) Submission Details - K991348

510(k) Number K991348 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 1999
Decision Date May 17, 2000
Days to Decision 394 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
233d slower than avg
Panel avg: 161d · This submission: 394d
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 K991348.
SCANDINAVIAN IVF SCIENCES AB, G1.2
K000625 · Vitrolife AB/Scandinavian Ivf Sciences AB · May 2000
SCANDINAVIAN IVF SCIENCES AB, GAMETE-100
K000626 · Vitrolife AB/Scandinavian Ivf Sciences AB · May 2000
SCANDINAVIAN IVF SCIENCES AB, THAW-KIT 1
K000618 · Vitrolife AB/Scandinavian Ivf Sciences AB · May 2000
SCANDINAVIAN IVF SCIENCES AB, SPERMRINSE -20/100
K000621 · Vitrolife AB/Scandinavian Ivf Sciences AB · May 2000
SCANDINAVIAN IVF SCIENCES AB, FREEZE-KIT 1
K000623 · 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
K991348 · IVF 20, IVF 50, IVF 500, IVF 500 ANTIBIOTIC FREE, MODELS 2420, 2004, 2501, 2500
Download PDF FDA Summary Vitrolife Sweden AB