510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K850657Substantially Equivalent

Thermal Diffusion Cerebral Blood Flow Monitor

Flowtronics, Inc., Phoenix AZ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K850657 is the FDA 510(k) clearance record for THERMAL DIFFUSION CEREBRAL BLOOD FLOW MONITOR, a class III device, cleared for Flowtronics, Inc. on under FDA product code LME (Monitor, Blood-Flow, Cerebral, Thermal Diffusion). FDA records list one 510(k) clearance for Flowtronics, Inc. As of , FDA records show no recalls naming K850657.

Clearance record

Decision date
Received
(25 days to decision)
Product code
LME Monitor, Blood-Flow, Cerebral, Thermal Diffusion
Device class
Class III
Review panel
Unknown
Applicant
Flowtronics, Inc. 10250 N. 19th Ave., Suite B, Phoenix AZ
Third party review
No

Clearances, product code LME

Trailing 12 months

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

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