510(k) · Cleared
ClearedBLUE 400
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carl Zeiss Meditec, AG · QFX Diagnostic Neurosurgical Microscope Filter
Cleared on Jul 22, 2022 as substantially equivalent to DEN180024 (Leica Microsystems (Schweiz) AG, 2019) after a 445-day review. Its family tree reaches back 1 generation to 2019. 2 later devices descend from it.
- Decided
- Jul 22, 2022
- Review
- 445 days
- Class
- Class II
- Product code
- QFX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN180024 (2019). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backDEN180024 Leica FL400Leica Microsystems (Schweiz) AG · 2019
- This deviceK211346 BLUE 400Carl Zeiss Meditec, AG · 2022
- Descendant · cites it directly · 0 of its ownK251286 Affirm 400Digital Surgery Systems, Inc. (D.B.A True Digital Surgery) · 2026
- Descendant · cites it directly · 0 of its ownK240215 Blue 400; Blue 400 SCarl Zeiss Meditec, AG · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN180024 | Leica FL400 | Leica Microsystems (Schweiz) AG | 2019 | — |
| 0 (this device) | K211346 | BLUE 400 | Carl Zeiss Meditec, AG | 2022 | — |
| +1 | K251286 | Affirm 400 | Digital Surgery Systems, Inc. (D.B.A True Digital Surgery) | 2026 | — |
| +1 | K240215 | Blue 400; Blue 400 S | Carl Zeiss Meditec, AG | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) 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
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN180024 | Leica FL400Summary page 4…ostic Neurosurgical Microscope Filter Regulatory Class: II Product Code: QFX 3. PREDICATE DEVICE Predicate Device: Leica FL400 (DEN180024) Classification: 21 CFR 882.4950 Diagnostic Neurosurgical Microscope Filter Regulatory Class: II Product Code: QFX… | 2019 |
What descends from it? (2)
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?
How does its category compare?
All QFX devicesQFX Diagnostic Neurosurgical Microscope Filter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211346 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211346: BLUE 400.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211346
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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