De Novo · Granted
GrantedCala ONE
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
Granted on Apr 26, 2018 as a new device type through De Novo after a 344-day review. 8 later devices descend from it.
- Decided
- Apr 26, 2018
- Review
- 344 days
- Class
- Class II
- Product code
- QBC
- Recalls
- None
8 later devices descend from it, 4 citing it directly.
- This deviceDEN170028 Cala ONECala Health, Inc. · 2018
- Descendant · cites it directly · 7 of its ownK182706 External upper limb tremor stimulatorCala Health, Inc. · 2018
- Descendant · cites it directly · 5 of its ownK203288 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
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K182706External upper limb tremor stimulatorCala Health, Inc. · 2018 · cites it directly7descendants
- K203288Cala TrioCala Health, Inc. · 2021 · cites it directly5descendants
- K222237Cala kIQCala Health, Inc. · 2022 · cites it directly3descendants
- K242259Cala kIQCala Health, Inc. · 2024 · 2 generations on2descendants
- K243848Cala kIQCala Health, Inc. · 2025 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN170028 | Cala ONE | Cala Health, Inc. | 2018 | — |
| +1 | K182706 | External upper limb tremor stimulator | Cala Health, Inc. | 2018 | — |
| +1 | 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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 0 |
Sources: FDA De Novo 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
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (8)
4 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?
- Of its descendants, K182706 (Cala Health, Inc., 2018) has gone furthest, with 7 descendants of its own.
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. 2018, 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 ONE device is indicated to aid in the transient relief of hand tremors in the treated hand following stimulation in adults with essential tremor.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN170028 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN170028: Cala ONE.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN170028
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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