Name: Predicase
Price: 199 USD

K-number	K240447
Device name	ThermoChem HT-2000 System and Intraperitoneal Hyperthermia (IPH) Procedure Kit (HT-2000)
Applicant	Thermasolutions, LLC
Product code	MLW
Device class	Class II
Decision date	May 5, 2025
Decision	Unknown
Regulation	876.5630

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

Researching this as a predicate?

Want a transparent AI-ranking score, AI-discovered related predicates, ongoing safety and warning-letter monitoring, full predicate chain lineage, and a drafted SE rationale — all saved to your own project? That's what an account adds.

Start free trial →

ThermoChem HT-2000 System and Intraperitoneal Hyperthermia (IPH) Procedure Kit (HT-2000)

Everything you need for a 510(k) submission. Nothing you don't.