510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K131583Substantially Equivalent

Thermochem Ht-2000

Thermasolutions LLC., Minneapolis MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K131583 is the FDA 510(k) clearance record for THERMOCHEM HT-2000, a class II device, cleared for Thermasolutions, Inc. on under FDA product code MLW (Warmer, Peritoneal Dialysate). FDA records list 3 510(k) clearances for Thermasolutions, Inc., from to . As of , FDA records show no recalls naming K131583.

Clearance record

Decision date
Received
(125 days to decision)
Product code
MLW Warmer, Peritoneal Dialysate
Regulation
21 CFR 876.5630
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Thermasolutions, Inc. 5353 Wayzata Blvd. Suite 505, Minneapolis MN
510(k) summary
Summary PDF
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