Cleared Traditional

K131145 - PROINSERT

K131145 is an FDA 510(k) clearance for PROINSERT, manufactured by Nidacon International AB. The device is a Class 2 Obstetrics & Gynecology device with product code MQK cleared through the Traditional 510(k) pathway after a 303-day FDA review.

K131145 · Nidacon International AB · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2014
Decision
303d
Days
Class 2
Risk

K131145 is an FDA 510(k) clearance for the PROINSERT. Classified as Labware, Assisted Reproduction (product code MQK), Class II - Special Controls.

Submitted by Nidacon International AB (Naples, US). The FDA issued a Cleared decision on February 20, 2014 after a review of 303 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 Nidacon International AB devices

FDA 510(k) Submission Details - K131145

510(k) Number K131145 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 2013
Decision Date February 20, 2014
Days to Decision 303 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
143d slower than avg
Panel avg: 160d · This submission: 303d
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 21
Devices cleared under the same product code (MQK) and FDA review panel - the closest regulatory comparables to K131145.
ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device (850µl, 3ml)
K173075 · Dxnow, Inc. · Mar 2018
iVitri Straw
K172751 · Reprobitech Corp. · Feb 2018
RAPID-I KIT
K140207 · Vitrolife Sweden AB · Dec 2014
RAPID-I
K090832 · Vitrolife Sweden AB · Dec 2009
SUNIVF DISHES
K080395 · Intl., Inc. · Aug 2008
GENX CULTURE DISH
K993881 · Intl., Inc. · Feb 2000