510(k) · Cleared
ClearedCala Trio
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cala Health, Inc. · QBC External Upper Limb Tremor Stimulator
Cleared on Oct 5, 2021 as substantially equivalent to DEN170028 (Cala Health, Inc., 2018) and 1 other predicate after a 330-day review. Its family tree reaches back 2 generations to 2018. 5 later devices descend from it.
- Decided
- Oct 5, 2021
- Review
- 330 days
- Class
- Class II
- Product code
- QBC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to DEN170028 (2018). 5 later devices descend from it, 2 citing it directly.
- Root · 2 generations backDEN170028 Cala ONECala Health, Inc. · 2018
- 1 generation backK182706 External upper limb tremor stimulatorCala Health, Inc. · 2018
- This deviceK203288 Cala TrioCala Health, Inc. · 2021
- Descendant · cites it directly · 3 of its ownK222237 Cala kIQCala Health, Inc. · 2022
- Descendant · 2 generations on · 2 of its ownK242259 Cala kIQCala Health, Inc. · 2024
- Descendant · 3 generations on · 1 of its ownK243848 Cala kIQCala Health, Inc. · 2025
- Descendant · 4 generations on · 0 of its ownK253587 Cala kIQ PlusCala Health, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK250096 Felix NeuroAI SystemFasikl Incorporated · 2025
Most influential descendants
Showing 5 of 5 · See all- K222237Cala kIQCala Health, Inc. · 2022 · cites it directly3descendants
- K242259Cala kIQCala Health, Inc. · 2024 · 2 generations on2descendants
- K243848Cala kIQCala Health, Inc. · 2025 · 3 generations on1descendant
- K253587Cala kIQ PlusCala Health, Inc. · 2026 · 4 generations on0descendants
- K250096Felix NeuroAI SystemFasikl Incorporated · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | DEN170028 | Cala ONE | Cala Health, Inc. | 2018 | — |
| −1 | K182706 | External upper limb tremor stimulator | Cala Health, Inc. | 2018 | — |
| 0 (this device) | K203288 | Cala Trio | Cala Health, Inc. | 2021 | — |
| +1 | K222237 | Cala kIQ | Cala Health, Inc. | 2022 | — |
| +2 | K242259 | Cala kIQ | Cala Health, Inc. | 2024 | — |
| +3 | K243848 | Cala kIQ | Cala Health, Inc. | 2025 | — |
| +4 | K253587 | Cala kIQ Plus | Cala Health, Inc. | 2026 | — |
| +1 | K250096 | Felix NeuroAI System | Fasikl Incorporated | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 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 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 4…21 CFR 882.5897 Product Code: QBC III. Predicate Device Predicate Device: Cala ONE Prior Submissions: DEN170028, K182706 Indications for Use: Cala ONE is indicated to aid in the transient relief… | 2018 |
| * | K182706 | External upper limb tremor stimulatorSummary page 3…SERVICES Form Approved: OMB No. 0910-0120 Food and Drug Administration Expiration Date: 06/30/2023 Indications for Use See PRA Statement below. 510(k) Number (if known) K182706 Device Name Cala Trio Indications for Use (Describe) The Cala Trio device is indicated to aid in the temporary relief of hand t… | 2018 |
What descends from it? (5)
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?
- The line of descent spans 3 years and passes through 1 company; a new generation was cleared every 2.9 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K222237 (Cala Health, Inc., 2022) has gone furthest, with 3 descendants of its own.
- 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. 2021, 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 Cala Trio device is indicated to aid in the temporary relief of hand tremors in the treated hand following stimulation in adults with essential tremor.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K203288 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203288: Cala Trio.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203288
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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