Cleared Traditional

K091939 - THERMEDX PRODIGY FLUID MANAGEMENT SYSTEM, MODELS P1000, P2000

K091939 is an FDA 510(k) clearance for THERMEDX PRODIGY FLUID MANAGEMENT SYSTEM, manufactured by Thermedx, LLC. The device is a Class 2 Obstetrics & Gynecology device with product code HIG cleared through the Traditional 510(k) pathway after a 388-day FDA review.

K091939 · Thermedx, LLC · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2010
Decision
388d
Days
Class 2
Risk

K091939 is an FDA 510(k) clearance for the THERMEDX PRODIGY FLUID MANAGEMENT SYSTEM, MODELS P1000, P2000. Classified as Insufflator, Hysteroscopic (product code HIG), Class II - Special Controls.

Submitted by Thermedx, LLC (Solon, US). The FDA issued a Cleared decision on July 23, 2010 after a review of 388 days - an unusually long review period, suggesting complex equivalence evaluation.

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

FDA 510(k) Submission Details - K091939

510(k) Number K091939 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 2009
Decision Date July 23, 2010
Days to Decision 388 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
227d slower than avg
Panel avg: 161d · This submission: 388d
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 45
Devices cleared under the same product code (HIG) and FDA review panel - the closest regulatory comparables to K091939.
HYSTEROSCOPY PUMP HM6
K123732 · W.O.M. World of Medicine AG · Apr 2013
AQUILEX FLUID CONTROL SYSTEM H112
K112642 · W.O.M. World of Medicine AG · Feb 2012
DOLPHIN 3 FLUID MANAGEMENT SYSTEM
K110852 · Gyrus Acmi, Inc. · Jul 2011
AQUASENS FLUID MONITORING SYSTEM
K031213 · Davol, Inc. · Apr 2003
HYSTEREOSCOPY PUMP HM4
K022449 · W.O.M. World of Medicine AG · Apr 2003
DOLPHIN II FLUID MANAGEMENT SYSTEM, MODEL DOL-2
K011876 · Circon Video · Jan 2002