Cleared Traditional

K090832 - RAPID-I

K090832 is an FDA 510(k) clearance for RAPID-I, 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 272-day FDA review.

K090832 · Vitrolife Sweden AB · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2009
Decision
272d
Days
Class 2
Risk

K090832 is an FDA 510(k) clearance for the RAPID-I. Classified as Labware, Assisted Reproduction (product code MQK), Class II - Special Controls.

Submitted by Vitrolife Sweden AB (Se-400 92 Goteborg, SE). The FDA issued a Cleared decision on December 23, 2009 after a review of 272 days - an extended review cycle.

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. Standard predicate reliance. 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 - K090832

510(k) Number K090832 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 2009
Decision Date December 23, 2009
Days to Decision 272 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
111d slower than avg
Panel avg: 161d · This submission: 272d
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 52
Devices cleared under the same product code (MQK) and FDA review panel - the closest regulatory comparables to K090832.
EEVATM PETRI DISH
K103028 · Auxogyn, Inc. · Aug 2011
CRYOPETTE
K100596 · Mid-Atlantic Diagnostics, Inc. · Dec 2010
HSV STRAW
K092398 · Cryo Bio System · Oct 2010
NUNC IVF CENTERWELL AND ICSI DISHES
K090429 · Thermo Fisher Scientific (Nalge Nunc Intl) · Sep 2009
BIOGENICS BIOQUAD 4-WELL IVF CULTURE DISH
K081896 · Biogenics, Inc. · Aug 2008
SUNIVF DISHES
K080395 · Intl., Inc. · Aug 2008
K090832 · RAPID-I
Download PDF FDA Summary Vitrolife Sweden AB