510(k) · Cleared
ClearedSonendo Omniclean Endotherpay System Console, Sonendo Omniclean Molar Procedure Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sonendo, Inc. · ELC Scaler, Ultrasonic
Cleared on May 15, 2014 as substantially equivalent to K130025 (Sonendo, Inc., 2013) and 2 other predicates after a 157-day review. Its family tree reaches back 2 generations to 2009. 2 later devices descend from it.
- Decided
- May 15, 2014
- Review
- 157 days
- Class
- Class II
- Product code
- ELC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K081268 (2009). 3 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK081268 Sonic Air MM1500 + (Mid), Model 50400014Micro-Mega Societe Anonyme · 2009
- 1 generation backK130025 Sonendo Endotherapy SystemSonendo, Inc. · 2013
- This deviceK133752 Sonendo Omniclean Endotherpay System Console, Sonendo Omniclean…Sonendo, Inc. · 2014
- Descendant · cites it directly · 1 of its ownK143448 Sonendo GentleWave SystemSonendo, Inc. · 2015
- Descendant · 2 generations on · 0 of its ownK233844 OdneCleanOdne AG · 2024
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 |
|---|---|---|---|---|---|
| −2 | K081268 | Sonic Air MM1500 + (Mid), Model 50400014 | Micro-Mega Societe Anonyme | 2009 | — |
| −1 | K130025 | Sonendo Endotherapy System | Sonendo, Inc. | 2013 | — |
| 0 (this device) | K133752 | Sonendo Omniclean Endotherpay System Console, Sonendo Omniclean Molar… | Sonendo, Inc. | 2014 | — |
| +1 | K143448 | Sonendo GentleWave System | Sonendo, Inc. | 2015 | — |
| +2 | K233844 | OdneClean | Odne AG | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2024 | 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? (3)
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 |
|---|---|---|---|
| * | K130025 | Sonendo Endotherapy SystemSummary page 1…r NAME: DEVICE Class 2, per 21 CFR 872.4850 CLASSIFICATION: PRODUCT CODE ELC PREDICATE DEVICES: Sonendo Endotherapy System (K130025) EMS Piezon Master 700 (K093000) Sonic Air MM 1500+ (MID) (KOS 1268) Subs… | 2013 |
| * | K093000 | Ems Piezon Master 700Summary page 1…872.4850 CLASSIFICATION: PRODUCT CODE ELC PREDICATE DEVICES: Sonendo Endotherapy System (K130025) EMS Piezon Master 700 (K093000) Sonic Air MM 1500+ (MID) (KOS 1268) Substantially Equivalent To: The Sonendo OmniClean Endotherapy… | 2010 |
| * | K081268 | Sonic Air MM1500 + (Mid), Model 50400014Summary page 2…Master 700 1500 + (MID) Sys t K172) ap Sstem (K(130025) (K093000) (K(081268) Preparation, Preparation, Various, Preparation, cleaning… | 2009 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K143448 | Sonendo GentleWave System | 2015 | 1 |
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 5 years and passes through 2 companies; a new generation was cleared every 3.8 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K143448 (Sonendo, Inc., 2015) has gone furthest, with 1 descendant 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. 2014, 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 OmniClean Endotherapy System is intended to prepare, clean and irrigate 1st and 2nd molar teeth indicated for root canal therapy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133752 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133752: Sonendo Omniclean Endotherpay System Console, Sonendo Omniclean Molar Procedure Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133752
Report an extraction error
Are you the manufacturer?
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