# K211346: BLUE 400

- Pathway: 510(k) (Traditional)
- Applicant: Carl Zeiss Meditec, AG
- Decided: Jul 22, 2022 after 445 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: 1 generation back to DEN180024 (2019). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN180024: Leica FL400, Leica Microsystems (Schweiz) AG (2019) Summary page 4.

## Most influential descendants
- K251286: Affirm 400 (2026), 0 descendants of its own
- K240215: Blue 400; Blue 400 S (2024), 0 descendants of its own

## Indications for use
BLUE 400 is an accessory of the surgical microscope and allows 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 is a surgical microscope accessory used in fluorescent visualization of suspected grade III and IV gliomas during neurosurgery.

Source page: https://510kreport.com/device/K211346
Methodology: https://510kreport.com/methodology