510(k) · Cleared
ClearedSonendo GentleWave System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sonendo, Inc. · ELC Scaler, Ultrasonic
Cleared on Jun 3, 2016 as substantially equivalent to K153157 (Sonendo, Inc., 2016) after a 63-day review. Its family tree reaches back 1 generation to 2016. 2 later devices descend from it.
- Decided
- Jun 3, 2016
- Review
- 63 days
- Class
- Class II
- Product code
- ELC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K153157 (2016). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK153157 Sonendo Gentle Wave SystemSonendo, Inc. · 2016
- This deviceK160905 Sonendo GentleWave SystemSonendo, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK203302 GentleWave XSonendo, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK190359 Sonendo GentleWave SystemSonendo, Inc. · 2019 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K153157 | Sonendo Gentle Wave System | Sonendo, Inc. | 2016 | — |
| 0 (this device) | K160905 | Sonendo GentleWave System | Sonendo, Inc. | 2016 | — |
| +1 | K203302 | GentleWave X | Sonendo, Inc. | 2021 | — |
| +1 | K190359 | Sonendo GentleWave System | Sonendo, Inc. | 2019 | 3 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2021 | 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 ELC? 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 ELC device
- #1 K260773 Varios Combi Pro2score 12.5 · 6 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 |
|---|---|---|---|
| * | K153157 | Sonendo Gentle Wave SystemSummary page 4…ler NAME: DEVICE Class 2, per 21 CFR 872.4850 CLASSIFICATION: PRODUCT CODE ELC PREDICATE DEVICES: Sonendo GentleWave® System (K153157) Description of the Device Subject to Premarket Notification: The Sonendo GentleWave® System is a medical device intended to pr… | 2016 |
What descends from it? (2)
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?
- Its one ancestor has no recall.
- Of its descendants, K203302 (Sonendo, Inc., 2021) has gone furthest, with 0 descendants of its own.
How does its category compare?
All ELC devicesELC Scaler, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · ELC
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ELC
104in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ELC
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ELC
284in 2025
MAUDE reports naming product code ELC, 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 | 6 | 92 | 0 | 12 |
| 2008 | 4 | 216 | 0 | 58 |
| 2009 | 4 | 121 | 0 | 108 |
| 2010 | 4 | 201 | 0 | 79 |
| 2011 | 3 | 122 | 0 | 5 |
| 2012 | 1 | — | 0 | 3 |
| 2013 | 13 | 174 | 0 | 6 |
| 2014 | 6 | 193 | 0 | 37 |
| 2015 | 5 | 150 | 0 | 135 |
| 2016 | 3 | 88 | 0 | 169 |
| 2017 | 2 | — | 0 | 356 |
| 2018 | 1 | — | 0 | 289 |
| 2019 | 4 | 192 | 0 | 302 |
| 2020 | 1 | — | 0 | 164 |
| 2021 | 3 | 196 | 0 | 166 |
| 2022 | 2 | — | 2 | 165 |
| 2023 | 5 | 258 | 0 | 210 |
| 2024 | 4 | 104 | 0 | 219 |
| 2025 | 2 | — | 0 | 284 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Sonendo GentleWave(R) System is intended to prepare, clean, and irrigate teeth indicated for root canal therapy.
When used with the Sonendo GentleWave(R) Molar Handpiece, the System is indicated for 1st and 2nd molar teeth.
When used with the Sonendo GentleWave(R) Anterior/Premolar Handpiece, the System is indicated for anterior and premolar teeth.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160905 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160905: Sonendo GentleWave System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160905
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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