510(k) · Cleared
ClearedFelix NeuroAI System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fasikl Incorporated · QBC External Upper Limb Tremor Stimulator
Cleared on Jul 1, 2025 as substantially equivalent to K203288 (Cala Health, Inc., 2021) after a 168-day review. Its family tree reaches back 3 generations to 2018.
- Decided
- Jul 1, 2025
- Review
- 168 days
- Class
- Class II
- Product code
- QBC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to DEN170028 (2018). 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 QBC? 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 QBC device
- #1 K243848 Cala kIQscore 12.9 · 5 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 |
|---|---|---|---|
| * | K203288 | Cala TrioSummary page 5…fication Name: External upper limb tremor stimulator (21 CFR 882.5897) Device Class: II Product Code: QBC 4. Predicate Device: 510(k) Number: K203288 Trade Name: Cala Trio Manufacturer: Cala Health, Inc 5. Date Prepared: June 24, 2025 6. Device Description: T… | 2021 |
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 2 companies; a new generation was cleared every 2.9 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K203288.
How does its category compare?
All QBC devicesQBC External Upper Limb Tremor Stimulator: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · QBC
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QBC
Too few QBC 510(k)s in any year since 2007 to give a median.
Recalls per year · QBC
No recall names QBC since 2007.
Adverse event reports per year · QBC
1in 2025
MAUDE reports naming product code QBC, not matched to any one device; reports are not rates.
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 | 2 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 1 |
| 2022 | 1 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 2 | — | 0 | 1 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Felix™ NeuroAI™ Wristband is indicated to aid in tremor-related functional limitations in the upper limbs in adults with essential tremor.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250096 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250096: Felix NeuroAI System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250096
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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