510(k) · Cleared
ClearedAffirm 400
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Digital Surgery Systems, Inc. (D.B.A True Digital Surgery) · QFX Diagnostic Neurosurgical Microscope Filter
Cleared on Jan 21, 2026 as substantially equivalent to K211346 (Carl Zeiss Meditec, AG, 2022) after a 271-day review. Its family tree reaches back 2 generations to 2019.
- Decided
- Jan 21, 2026
- Review
- 271 days
- Class
- Class II
- Product code
- QFX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN180024 (2019). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 K211346 BLUE 400score 9.7 · 1 generation · 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 |
|---|---|---|---|
| * | K211346 | BLUE 400Summary page 5…882.4950 PRODUCT CODE: QFX 3. PREDICATE DEVICE PREDICATE DEVICE: BLUE 400 (K211346) from Carl Zeiss Meditec AG DEVICE CLASS: Class II CLASSIFICATION NAME:… | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 7 years and passes through 3 companies; a new generation was cleared every 3.5 years on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K211346.
How does its category compare?
All QFX devicesQFX Diagnostic Neurosurgical Microscope Filter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251286 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251286: Affirm 400.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251286
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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