510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K993330Substantially Equivalent

Thermochem-Ht System

Hemocleanse, Inc., West Lafayette IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K993330 is the FDA 510(k) clearance record for THERMOCHEM-HT SYSTEM, a class II device, cleared for Hemocleanse, Inc. on under FDA product code MLW (Warmer, Peritoneal Dialysate). FDA records list 5 510(k) clearances for Hemocleanse, Inc., from to . As of , FDA records show no recalls naming K993330.

Clearance record

Decision date
Received
(87 days to decision)
Product code
MLW Warmer, Peritoneal Dialysate
Regulation
21 CFR 876.5630
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Hemocleanse, Inc. 2700 Kent Ave., West Lafayette IN
510(k) summary
Summary
Third party review
No

Clearances, product code MLW

Trailing 12 months

FDA records hold no clearances under product code MLW in the trailing twelve months.

FDA records show no clearances under product code MLW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MLW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260