510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K945853Substantially Equivalent for Some Indications

Thermotek H-300

Thermotek, Inc., Carrollton TX / Traditional, Substantially Equivalent for Some Indications
FDA source (opens on fda.gov)

K945853 is the FDA 510(k) clearance record for THERMOTEK H-300, a class II device, cleared for Thermotek, Inc. on under FDA product code ILO (Pack, Hot Or Cold, Water Circulating). FDA records list 4 510(k) clearances for Thermotek, Inc., from to . As of , FDA records show no recalls naming K945853.

Clearance record

Decision date
Received
(339 days to decision)
Product code
ILO Pack, Hot Or Cold, Water Circulating
Regulation
21 CFR 890.5720
Device class
Class II
Review panel
Physical Medicine
Applicant
Thermotek, Inc. 3330 Earhart Dr., Suite 212, Carrollton TX
Third party review
No

Clearances, product code ILO

Trailing 12 months

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

FDA records show no clearances under product code ILO in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code ILO, 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