510(k) · Cleared
ClearedEncora X1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Encora, Inc. · QBC External Upper Limb Tremor Stimulator
Cleared on Feb 5, 2026 as substantially equivalent to DEN170028 (Cala Health, Inc., 2018) and 1 other predicate after a 265-day review. Its family tree reaches back 2 generations to 2018.
- Decided
- Feb 5, 2026
- Review
- 265 days
- Class
- Class II
- Product code
- QBC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 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? (2)
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 |
|---|---|---|---|
| * | DEN170028 | Cala ONESummary page 5…n: 21 CFR 882.5897 Product Code: QBC 3. Predicate Device Predicate Device: Cala ONE Submission Numbers: DEN170028, K182706 Indications for Use: Cala ONE is indicated to aid in the transient relief of hand… | 2018 |
| * | K182706 | External upper limb tremor stimulatorSummary page 5…21 CFR 882.5897 Product Code: QBC 3. Predicate Device Predicate Device: Cala ONE Submission Numbers: DEN170028, K182706 Indications for Use: Cala ONE is indicated to aid in the transient relief of hand tr… | 2018 |
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 8 years and passes through 2 companies; a new generation was cleared every 7.3 years on median.
- None of the 2 ancestors has a recall.
- 3 other devices also cite its predicate DEN170028.
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. 2026, 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?
Encora X1 is indicated to aid in the relief of hand tremors in the treated limb during stimulation in adults with essential tremor.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251517 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251517: Encora X1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251517
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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