510(k) · Cleared
Recalled · Class II · 2025Myriad SPECTRA Light Source
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nico Corporation · QFX Diagnostic Neurosurgical Microscope Filter
Cleared on Mar 14, 2024 as substantially equivalent to DEN180024 (Leica Microsystems (Schweiz) AG, 2019) after a 203-day review. Its family tree reaches back 1 generation to 2019. It has been recalled once.
- Decided
- Mar 14, 2024
- Review
- 203 days
- Class
- Class II
- Product code
- QFX
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN180024 (2019). No later device cites it as a predicate yet.
- Root · 1 generation backDEN180024 Leica FL400Leica Microsystems (Schweiz) AG · 2019
- This deviceK232567 Myriad SPECTRA Light SourceNico Corporation · 2024
View 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) | K232567 | Myriad SPECTRA Light Source | Nico Corporation | 2024 | — |
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 5…Diagnostic Neurosurgical Microscope Filter Classification 21 CFR 882.4950 (Class II) Product Code QFX Predicate Device DEN180024, Leica FL400 Device Description The Myriad SPECTRA Light Source used with the NICO Illumination Fiber and the NICO Delivery Sle… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 31, 2025 | Class II | Z-0600-2026 | Under Investigation by firm | Tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergic reaction. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 1 other device also cites its predicate DEN180024.
How does its category compare?
All QFX devicesQFX Diagnostic Neurosurgical Microscope Filter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 Myriad SPECTRA Light Source is an accessory to the Myriad System and delivers white light as well as excitation
light for blue spectral range of 399 - 411 nm for use with an appropriate surgical microscope and fluorophore.
The Myriad SPECTRA Light Source is used to provide supplemental excitation light for fluorescent visualization of
suspected grade III or IV gliomas during neurosurgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232567 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232567: Myriad SPECTRA Light Source.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232567
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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