Cleared Traditional

K091939 - THERMEDX PRODIGY FLUID MANAGEMENT SYSTEM, MODELS P1000, P2000 (FDA 510(k) Clearance)

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K091939 · Thermedx, LLC · Obstetrics & Gynecology device
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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.

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Submission Details

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
Regulatory Context
Review time vs. panel average
228d slower than avg
Panel avg: 160d · This submission: 388d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.