De Novo · Granted
GrantedLeica FL400
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Leica Microsystems (Schweiz) AG · QFX Diagnostic Neurosurgical Microscope Filter
Granted on Mar 28, 2019 as a new device type through De Novo after a 335-day review. 4 later devices descend from it.
- Decided
- Mar 28, 2019
- Review
- 335 days
- Class
- Class II
- Product code
- QFX
- Recalls
- None
4 later devices descend from it, 2 citing it directly.
- This deviceDEN180024 Leica FL400Leica Microsystems (Schweiz) AG · 2019
- Descendant · cites it directly · 2 of its ownK211346 BLUE 400Carl Zeiss Meditec, AG · 2022
- Descendant · 2 generations on · 0 of its ownK251286 Affirm 400Digital Surgery Systems, Inc. (D.B.A True Digital Surgery) · 2026
- Descendant · 2 generations on · 0 of its ownK240215 Blue 400; Blue 400 SCarl Zeiss Meditec, AG · 2024
- Descendant · cites it directly · 0 of its ownK232567 Myriad SPECTRA Light SourceNico Corporation · 2024 · Recalled
Most influential descendants
Showing 4 of 4 · See all- K211346BLUE 400Carl Zeiss Meditec, AG · 2022 · cites it directly2descendants
- K251286Affirm 400Digital Surgery Systems, Inc. (D.B.A True Digital Surgery) · 2026 · 2 generations on0descendants
- K240215Blue 400; Blue 400 SCarl Zeiss Meditec, AG · 2024 · 2 generations on0descendants
- K232567Myriad SPECTRA Light SourceNico Corporation · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN180024 | Leica FL400 | Leica Microsystems (Schweiz) AG | 2019 | — |
| +1 | K211346 | BLUE 400 | Carl Zeiss Meditec, AG | 2022 | — |
| +2 | K251286 | Affirm 400 | Digital Surgery Systems, Inc. (D.B.A True Digital Surgery) | 2026 | — |
| +2 | K240215 | Blue 400; Blue 400 S | Carl Zeiss Meditec, AG | 2024 | — |
| +1 | K232567 | Myriad SPECTRA Light Source | Nico Corporation | 2024 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2024 | 2 | 0 |
| 2026 | 1 | 0 |
Sources: FDA De Novo database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QFX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QFX device
- #1 K251286 Affirm 400score 11.0 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K211346 (Carl Zeiss Meditec, AG, 2022) has gone furthest, with 2 descendants of its own.
How does its category compare?
All QFX devicesQFX Diagnostic Neurosurgical Microscope Filter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · QFX
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · QFX
Too few QFX 510(k)s in any year since 2007 to give a median.
Recalls per year · QFX
No recall names QFX since 2007.
Adverse event reports per year · QFX
No MAUDE report names QFX since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Leica FL400 is a surgical microscope accessory filter set for viewing fluorescence of fluorophores comprising an excitation filter for blue spectral range 380 nm – 430 nm and an observation filter comprising the long-wave blue, green, yellow and red spectrum in the spectral band greater than 444 nm.
The FL400 is a surgical microscope accessory used in fluorescent visualization of suspected grade III or IV gliomas during neurosurgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN180024 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN180024: Leica FL400.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN180024
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026