510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K950350Substantially Equivalent

Themalator. Models T-4-S, T-8-S, Etc.

Whitehall/Div Columbus Mckennon Corp., City Of Industry CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K950350 is the FDA 510(k) clearance record for THEMALATOR. MODELS T-4-S, T-8-S, ETC., a class I device, cleared for Whitehall/Div Columbus Mckennon Corp. on under FDA product code IRQ (Unit, Heating, Powered). FDA records list one 510(k) clearance for Whitehall/Div Columbus Mckennon Corp. As of , FDA records show no recalls naming K950350.

Clearance record

Decision date
Received
(53 days to decision)
Product code
IRQ Unit, Heating, Powered
Regulation
21 CFR 890.5950
Device class
Class I
Review panel
Physical Medicine
Applicant
Whitehall/Div Columbus Mckennon Corp. 15058 Proctor Ave., City Of Industry CA
510(k) summary
Summary
Third party review
No

Clearances, product code IRQ

Trailing 12 months

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

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