510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K211346Substantially Equivalent

Blue 400

Carl Zeiss Meditec Inc, Jena, DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K211346 is the FDA 510(k) clearance record for BLUE 400, a class II device, cleared for Carl Zeiss Meditec, AG on under FDA product code QFX (Diagnostic Neurosurgical Microscope Filter). FDA's definition for product code QFX reads: "A diagnostic neurosurgical microscope filter is a device intended for use during neurosurgery to visualize fluorescence and enhance visualization of tissue associated with a specific disease or condition". FDA records list 78 510(k) clearances for Carl Zeiss Meditec, AG, from to . As of , FDA records show no recalls naming K211346.

Clearance record

Decision date
Received
(445 days to decision)
Product code
QFX Diagnostic Neurosurgical Microscope Filter
Regulation
21 CFR 882.4950
Device class
Class II
Review panel
Neurology
Applicant
Carl Zeiss Meditec, AG Goeschwitzer Strasse 51-52, Jena, DE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QFX

Trailing 12 months
1 clearance under product code QFX in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code QFX, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260