Cleared Traditional

K140207 - RAPID-I KIT

K140207 is the FDA 510(k) clearance for RAPID-I KIT by Vitrolife Sweden AB. It is a Class 2 Obstetrics & Gynecology device (product code MQK) cleared through the Traditional 510(k) pathway after a 324-day FDA review.

K140207 · Vitrolife Sweden AB · Obstetrics & Gynecology device
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Dec 2014
Decision
324d
Days
Class 2
Risk

K140207 is an FDA 510(k) clearance for the RAPID-I KIT. Classified as Labware, Assisted Reproduction (product code MQK), Class II - Special Controls.

Submitted by Vitrolife Sweden AB (Washington, US). The FDA issued a Cleared decision on December 18, 2014 after a review of 324 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.6160 - 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.

View all Vitrolife Sweden AB devices

Submission Details

510(k) Number K140207 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 2014
Decision Date December 18, 2014
Days to Decision 324 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
164d slower than avg
Panel avg: 160d · This submission: 324d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MQK Labware, Assisted Reproduction
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.6160
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.