# K240215: Blue 400; Blue 400 S

- Pathway: 510(k) (Traditional)
- Applicant: Carl Zeiss Meditec, AG
- Decided: Jun 28, 2024 after 154 days
- Product code: QFX (Diagnostic Neurosurgical Microscope Filter)
- Device class: 2
- Regulation: 21 CFR 882.4950
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to DEN180024 (2019). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211346: BLUE 400, Carl Zeiss Meditec, AG (2022) Summary page 6.

## Indications for use
BLUE 400 and BLUE 400 S are accessories to the surgical microscope and allow the fluorescence observation of fluorophores with an excitation peak between 400 nm and 410 nm and the fluorescence emission observation comprising the spectrum in a spectral band of 620 - 710 nm. The ZEISS BLUE 400 and BLUE 400 S are surgical microscope accessories used in fluorescent visualization of suspected grade III and IV gliomas during neurosurgery.

Source page: https://510kreport.com/device/K240215
Methodology: https://510kreport.com/methodology