510(k) · Cleared
ClearedEndo Ultrasonic Activator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Foshan Coxo Medical Instrument Co., Ltd. · ELC Scaler, Ultrasonic
Cleared on Mar 23, 2023 as substantially equivalent to K053555 (Guilin Woodpecker Medical Instrument Co., Ltd., 2006) after a 248-day review. Its family tree reaches back 1 generation to 2006.
- Decided
- Mar 23, 2023
- Review
- 248 days
- Class
- Class II
- Product code
- ELC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K053555 (2006). No later device cites it as a predicate yet.
- Root · 1 generation backK053555 Ultrasonic Scaler, Models Uds-N1, Uds-N2. Uds-J, Uds-K, Uds-LGuilin Woodpecker Medical Instrument Co., Ltd. · 2006
- This deviceK222096 Endo Ultrasonic ActivatorFoshan Coxo Medical Instrument Co., Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K053555 | Ultrasonic Scaler, Models Uds-N1, Uds-N2. Uds-J, Uds-K, Uds-L | Guilin Woodpecker Medical Instrument Co., Ltd. | 2006 | — |
| 0 (this device) | K222096 | Endo Ultrasonic Activator | Foshan Coxo Medical Instrument Co., Ltd. | 2023 | — |
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 |
|---|---|---|---|
| * | K053555 | Ultrasonic Scaler, Models Uds-N1, Uds-N2. Uds-J, Uds-K, Uds-LSummary page 5…flow effect generated by the ultrasonic vibration to wash the root canal swing. 5. Identification of Predicate Device(s) Predicate Device 510(k) Number: K053555 Product Name: Ultrasonic Scaler(Model: UDS-L) Manufacturer: Guilin Woodpecker Medical Instrument Company, Limited 6.… | 2006 |
| † | K213947 | Ultrasonic Endo Activation Device (Model:Actor I pro) | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
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.
- 1 other device also cites its predicate K053555.
How does its category compare?
All ELC devicesELC Scaler, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
For root canal cleaning.
The instrument must only be used in hospital environments, clinics or dental offices, by qualified practitioners.
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/K222096 · printed Nov 5, 2026
Cite this page
510(k) Report. “K222096: Endo Ultrasonic Activator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K222096
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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