Cleared Traditional

K112642 - AQUILEX FLUID CONTROL SYSTEM H112

K112642 is an FDA 510(k) clearance for AQUILEX FLUID CONTROL SYSTEM H112, manufactured by W.O.M. World of Medicine AG. The device is a Class 2 Obstetrics & Gynecology device with product code HIG cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K112642 · W.O.M. World of Medicine AG · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2012
Decision
147d
Days
Class 2
Risk

K112642 is an FDA 510(k) clearance for the AQUILEX FLUID CONTROL SYSTEM H112. Classified as Insufflator, Hysteroscopic (product code HIG), Class II - Special Controls.

Submitted by W.O.M. World of Medicine AG (Cambridge, US). The FDA issued a Cleared decision on February 6, 2012 after a review of 147 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1700 - 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.

View all W.O.M. World of Medicine AG devices

FDA 510(k) Submission Details - K112642

510(k) Number K112642 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 2011
Decision Date February 06, 2012
Days to Decision 147 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
13d faster than avg
Panel avg: 160d · This submission: 147d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HIG Device Classification - Class 2, Special Controls

Product Code HIG Insufflator, Hysteroscopic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1700
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 - HIG Insufflator, Hysteroscopic

All 28
Devices cleared under the same product code (HIG) and FDA review panel - the closest regulatory comparables to K112642.
Fluent Fluid Management System
K180825 · Hologic, Inc. · Aug 2018
GYN-Pump PH304
K173489 · W.O.M. World of Medicine GmbH · Mar 2018
Aquilex Fluid Control System AQL-100S
K172040 · W.O.M. World of Medicine GmbH · Feb 2018
DOLPHIN 3 FLUID MANAGEMENT SYSTEM
K110852 · Gyrus Acmi, Inc. · Jul 2011
AQUASENS FLUID MONITORING SYSTEM
K031213 · Davol, Inc. · Apr 2003
KARL STORZ HYSTEROMAT II
K000806 · KARL STORZ Endoscopy-America, Inc. · Nov 2000