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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
142d slower than avg
Panel avg: 161d · 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 49
Devices cleared under the same product code (MQK) and FDA review panel - the closest regulatory comparables to K131145.
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
CRYOLOCK
K122982 · Biotech, Inc. · Jan 2014
CULTURE DISH 40 MM, CULTURE DISH 60 MM, MICRO DROPLET CULTURE DISH, 5 WELL CULTURE DISH, CENTRE WELL DISH, ICSI DISH
K123641 · Hertart · Jul 2013
SEAFORIA SPERM SEPARATION ASSISTANCE SYSTEM
K112644 · Lotus Bio, Ltd. · Dec 2012