Cleared Traditional

K240447 - ThermoChem HT-2000 System and Intraperitoneal Hyperthermia (IPH) Procedure Kit (HT-2000) (FDA 510(k) Clearance)

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

K240447 · Thermasolutions, LLC · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
May 2025
Decision
445d
Days
Class 2
Risk

K240447 is an FDA 510(k) clearance for the ThermoChem HT-2000 System and Intraperitoneal Hyperthermia (IPH) Procedure Ki.... Classified as Warmer, Peritoneal Dialysate (product code MLW), Class II - Special Controls.

Submitted by Thermasolutions, LLC (White Bear Lake, US). The FDA issued a Cleared decision on May 5, 2025 after a review of 445 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5630 - the FDA gastroenterology and urology 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Thermasolutions, LLC devices

Submission Details

510(k) Number K240447 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received February 15, 2024
Decision Date May 05, 2025
Days to Decision 445 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
315d slower than avg
Panel avg: 130d · This submission: 445d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MLW Warmer, Peritoneal Dialysate
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5630
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Consultant

DuVal & Associates, P.A.
Jessica Czamanski

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.