Cleared Special

K172040 - Aquilex Fluid Control System AQL-100S

K172040 is an FDA 510(k) clearance for Aquilex Fluid Control System AQL-100S, manufactured by W.O.M. World of Medicine GmbH. The device is a Class 2 Obstetrics & Gynecology device with product code HIG cleared through the Special 510(k) pathway after a 215-day FDA review.

K172040 · W.O.M. World of Medicine GmbH · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2018
Decision
215d
Days
Class 2
Risk

K172040 is an FDA 510(k) clearance for the Aquilex Fluid Control System AQL-100S. Classified as Insufflator, Hysteroscopic (product code HIG), Class II - Special Controls.

Submitted by W.O.M. World of Medicine GmbH (Berlin, DE). The FDA issued a Cleared decision on February 5, 2018 after a review of 215 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1700 - the FDA obstetrics and gynecology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K172040

510(k) Number K172040 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 2017
Decision Date February 05, 2018
Days to Decision 215 days
Submission Type Special
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
54d slower than avg
Panel avg: 161d · This submission: 215d
Pathway characteristics
Modification to existing cleared device.

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 Consultant

Susanne Raab
Susanne Raab

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HIG Insufflator, Hysteroscopic

All 56
Devices cleared under the same product code (HIG) and FDA review panel - the closest regulatory comparables to K172040.
Endomat Select
K180735 · Karl Storz SE & CO. KG · Oct 2018
Fluent Fluid Management System
K180825 · Hologic, Inc. · Aug 2018
GYN-Pump PH304
K173489 · W.O.M. World of Medicine GmbH · Mar 2018
FluidSmart
K172048 · Thermedx, LLC · Sep 2017
THERMEDX FLUID MANAGMENT SYSTEM
K133799 · Thermedx, LLC · Jun 2014
HYSTEROSCOPY PUMP HM6
K123732 · W.O.M. World of Medicine AG · Apr 2013
K172040 · Aquilex Fluid Control System AQL-100S
Download PDF FDA Summary W.O.M. World of Medic…