Cleared Traditional

K001113 - IVC THREE BLASTOCYST MEDIUM, CAT # 2007

K001113 is an FDA 510(k) clearance for IVC THREE BLASTOCYST MEDIUM, manufactured by Invitrocare, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code MQL cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K001113 · Invitrocare, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2000
Decision
68d
Days
Class 2
Risk

K001113 is an FDA 510(k) clearance for the IVC THREE BLASTOCYST MEDIUM, CAT # 2007. Classified as Media, Reproductive (product code MQL), Class II - Special Controls.

Submitted by Invitrocare, Inc. (San Diego, US). The FDA issued a Cleared decision on June 13, 2000 after a review of 68 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 - K001113

510(k) Number K001113 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 2000
Decision Date June 13, 2000
Days to Decision 68 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
93d faster than avg
Panel avg: 161d · This submission: 68d
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 K001113.
MEDI-CULT M3 MEDIUM
K991331 · Medicult A/S · Jun 2000
MEDI-CULT HYALURONIDASE
K991334 · Medicult A/S · Jun 2000
SCANDINAVIAN IVF SCIENCES AB, HYBASE-1
K000627 · Vitrolife AB/Scandinavian Ivf Sciences AB · Jun 2000
SPERM WASH MEDIUM, CAT# 2003/2005
K000989 · Invitrocare, Inc. · Jun 2000
IVC TWO MEDIUM
K000937 · Invitrocare, Inc. · May 2000
IVC ONE MEDIUM
K000938 · Invitrocare, Inc. · May 2000
K001113 · IVC THREE BLASTOCYST MEDIUM, CAT # 2007
Download PDF FDA Summary Invitrocare, Inc.