510(k) · Cleared
ClearedExternal upper limb tremor stimulator
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 25, 2018 as substantially equivalent to DEN170028 (Cala Health, Inc., 2018) after a 28-day review. Its family tree reaches back 1 generation to 2018. 7 later devices descend from it.
- Decided
- Oct 25, 2018
- Review
- 28 days
- Class
- Class II
- Product code
- QBC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN170028 (2018). 7 later devices descend from it, 3 citing it directly.
- Root · 1 generation backDEN170028 Cala ONECala Health, Inc. · 2018
- This deviceK182706 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
- Descendant · 4 generations on · 0 of its ownK253587 Cala kIQ PlusCala Health, Inc. · 2026
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- 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
- K253587Cala kIQ PlusCala Health, Inc. · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN170028 | Cala ONE | Cala Health, Inc. | 2018 | — |
| 0 (this device) | 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 | — |
| +4 | K253587 | Cala kIQ Plus | Cala Health, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 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? (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 |
|---|---|---|---|
| * | DEN170028 | Cala ONESummary page 4…r Regulation: 21 CFR 882.5897 Product Code: QBC III. Predicate Device Name: Cala ONE Prior submission: DEN170028 IV. Description of Device and Modification As described in DEN170028, the Cala ONE is a small, lightweig… | 2018 |
What descends from it? (7)
3 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?
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/K182706 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182706: External upper limb tremor stimulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182706
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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