510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K953905Substantially Equivalent

Imperium

Teledyne Brown Engineering, Huntsville AL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K953905 is the FDA 510(k) clearance record for IMPERIUM, a class II device, cleared for Teledyne Brown Engineering on under FDA product code IQA (System, Environmental Control, Powered). FDA records list 2 510(k) clearances for Teledyne Brown Engineering, from to . As of , FDA records show no recalls naming K953905.

Clearance record

Decision date
Received
(95 days to decision)
Product code
IQA System, Environmental Control, Powered
Regulation
21 CFR 890.3725
Device class
Class II
Review panel
Physical Medicine
Applicant
Teledyne Brown Engineering Cummings Research Park, Huntsville AL
510(k) summary
Summary
Third party review
No

Clearances, product code IQA

Trailing 12 months

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

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