# K251286: Affirm 400

- Pathway: 510(k) (Traditional)
- Applicant: Digital Surgery Systems, Inc. (D.B.A True Digital Surgery)
- Decided: Jan 21, 2026 after 271 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 5.

## Indications for use
Affirm 400 is a surgical microscope accessory used in fluorescent visualization of suspected grade III and IV gliomas during neurosurgery, comprising an excitation filter for blue spectral range between 390 nm and 420 nm and an observation filter for visible light with spectral range between 510 nm and 700 nm.

Source page: https://510kreport.com/device/K251286
Methodology: https://510kreport.com/methodology