510(k) · Cleared
ClearedEndo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Rogin Medical Co., Ltd. · EKX Handpiece, Direct Drive, Ac-Powered
Cleared on Apr 24, 2025 as substantially equivalent to K203320 (Guilin Woodpecker Medical Instrument Co., Ltd., 2021) after a 244-day review. Its family tree reaches back 3 generations to 1997.
- Decided
- Apr 24, 2025
- Review
- 244 days
- Class
- Class I
- Product code
- EKX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K970339 (1997). No later device cites it as a predicate yet.
- Root · 3 generations backK970339 Tri Auto ZXJ. Morita USA, Inc. · 1997
- 2 generations backK170275 Tri Auto ZX2J. Morita USA, Inc. · 2017
- 1 generation backK203320 Endo MotorGuilin Woodpecker Medical Instrument Co., Ltd. · 2021
- This deviceK242514 Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO)Shenzhen Rogin Medical Co., Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K970339 | Tri Auto ZX | J. Morita USA, Inc. | 1997 | — |
| −2 | K170275 | Tri Auto ZX2 | J. Morita USA, Inc. | 2017 | — |
| −1 | K203320 | Endo Motor | Guilin Woodpecker Medical Instrument Co., Ltd. | 2021 | — |
| 0 (this device) | K242514 | Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO) | Shenzhen Rogin Medical Co., Ltd. | 2025 | — |
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 EKX? 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 EKX device
- #1 K261987 Reusable SmartPegscore 13.2 · 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 |
|---|---|---|---|
| * | K203320 | Endo MotorSummary page 5…Accessories Product Code: EKX Regulation Number: 872.4200 Class: Class 1 Review Panel: Dental 4. Predicate Device Information: 510(k) Number: K203320 Sponsor: Guilin Woodpecker Medical Instrument Co., Ltd. 1 page … | 2021 |
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?
- The line of descent spans 28 years and passes through 3 companies; a new generation was cleared every 4.0 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All EKX devicesEKX Handpiece, Direct Drive, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · EKX
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EKX
244in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EKX
No recall names EKX since 2007.
Adverse event reports per year · EKX
9in 2025
MAUDE reports naming product code EKX, 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 | 1 | — | 0 | 9 |
| 2008 | 3 | 101 | 0 | 10 |
| 2009 | 4 | 186 | 0 | 11 |
| 2010 | 3 | 114 | 0 | 20 |
| 2011 | 4 | 75 | 0 | 6 |
| 2012 | 2 | — | 0 | 27 |
| 2013 | 2 | — | 0 | 45 |
| 2014 | 3 | 251 | 0 | 102 |
| 2015 | 3 | 178 | 0 | 68 |
| 2016 | 3 | 274 | 0 | 66 |
| 2017 | 2 | — | 0 | 10 |
| 2018 | 3 | 293 | 0 | 49 |
| 2019 | 3 | 349 | 0 | 56 |
| 2020 | 1 | — | 0 | 67 |
| 2021 | 5 | 214 | 0 | 79 |
| 2022 | 3 | 359 | 0 | 37 |
| 2023 | 4 | 152 | 0 | 14 |
| 2024 | 4 | 276 | 0 | 19 |
| 2025 | 5 | 244 | 0 | 9 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Endo Motor with E-LITE MAX, E-LITE PRO and ELITE-INO is cordless endodontic treatment motorized handpiece with root canal measurement capability. It can be used for preparation and enlargement of root canals, or measuring the canal length. And it can be used to enlarge the canal while monitoring the position of the file tip inside the canal.
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/K242514 · printed Nov 3, 2026
Cite this page
510(k) Report. “K242514: Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K242514
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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