Cleared Traditional

K140207 - RAPID-I KIT

K140207 is an FDA 510(k) clearance for RAPID-I KIT, manufactured by Vitrolife Sweden AB. The device is a Class 2 Obstetrics & Gynecology device with 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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Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K140207

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.

MQK Device Classification - Class 2, Special Controls

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.

Regulatory Peers - MQK Labware, Assisted Reproduction

All 40
Devices cleared under the same product code (MQK) and FDA review panel - the closest regulatory comparables to K140207.
Cryotop US
K153027 · Kitazato Biopharma Co;Ltd · Mar 2016
EmbryoSlide Culture Dish
K150961 · Vitrolife A/S · Dec 2015
Micro well group culture dish, 9-well
K150756 · Hertart · Jul 2015
EEVA DISH (WITH 12 MICROWELLS)
K141663 · Auxogyn, Inc. · Jul 2014
QUALIS
K133295 · Menicon Co., Ltd. New Business Division · Jun 2014
CRYOTOP(R) SC
K140072 · Kitazato Biopharma Co;Ltd · Apr 2014