510(k) · Cleared
ClearedApex Locator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Rogin Medical Co., Ltd. · LQY Locator, Root Apex
Cleared on Mar 7, 2025 as substantially equivalent to K212178 (Foshan Coxo Medical Instrument Co., Ltd., 2022) after a 207-day review. Its family tree reaches back 6 generations to 1999.
- Decided
- Mar 7, 2025
- Review
- 207 days
- Class
- Class U
- Product code
- LQY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K992233 (1999). No later device cites it as a predicate yet.
- Root · 6 generations backK992233 Apex Locator Bingo-1020Dent Corp. Research & Development · 1999
- 5 generations backK111474 Bingo ProForum Engineering Technologies (96), Ltd. · 2011
- 4 generations backK131907 Raypex 6Dentsply International, Inc. · 2014
- 3 generations backK191806 Propex IQ Apex LocatorDentsply Sirona · 2019
- 2 generations backK203836 BOMEDENT Apex locator, WISMY Apex locatorChangzhou Bomedent Medical Technology Co.,Ltd · 2021
- 1 generation backK212178 Root Apex LocatorFoshan Coxo Medical Instrument Co., Ltd. · 2022
- This deviceK242383 Apex LocatorShenzhen Rogin Medical Co., Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K992233 | Apex Locator Bingo-1020 | Dent Corp. Research & Development | 1999 | — |
| −5 | K111474 | Bingo Pro | Forum Engineering Technologies (96), Ltd. | 2011 | — |
| −4 | K131907 | Raypex 6 | Dentsply International, Inc. | 2014 | — |
| −3 | K191806 | Propex IQ Apex Locator | Dentsply Sirona | 2019 | — |
| −2 | K203836 | BOMEDENT Apex locator, WISMY Apex locator | Changzhou Bomedent Medical Technology Co.,Ltd | 2021 | — |
| −1 | K212178 | Root Apex Locator | Foshan Coxo Medical Instrument Co., Ltd. | 2022 | — |
| 0 (this device) | K242383 | Apex Locator | 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 LQY? 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 LQY device
- #1 K252224 Apex Locator (FindPex)score 12.0 · 4 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 |
|---|---|---|---|
| * | K212178 | Root Apex LocatorSummary page 5…mendment Class: Unclassified Review Panel: Dental Device Name: Apex Locator Model：APEX-S, APEX-R 3. Predicate Device Information: 510(k) Number: K212178 Device Classification Name: Locator, Root apex Sponsor: Foshan COXO Medical Instrument Co., Ltd. Classification Prod… | 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?
- The line of descent spans 26 years and passes through 7 companies; a new generation was cleared every 2.6 years on median.
- None of the 6 ancestors has a recall.
How does its category compare?
All LQY devicesLQY Locator, Root Apex: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · LQY
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LQY
164in 2010
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LQY
No recall names LQY since 2007.
Adverse event reports per year · LQY
51in 2025
MAUDE reports naming product code LQY, 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 | 2 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 1 |
| 2009 | 2 | — | 0 | 15 |
| 2010 | 3 | 164 | 0 | 22 |
| 2011 | 2 | — | 0 | 140 |
| 2012 | 2 | — | 0 | 59 |
| 2013 | 1 | — | 0 | 2 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 59 |
| 2016 | 1 | — | 0 | 128 |
| 2017 | 0 | — | 0 | 133 |
| 2018 | 2 | — | 0 | 154 |
| 2019 | 1 | — | 0 | 163 |
| 2020 | 0 | — | 0 | 139 |
| 2021 | 2 | — | 0 | 107 |
| 2022 | 1 | — | 0 | 63 |
| 2023 | 1 | — | 0 | 56 |
| 2024 | 1 | — | 0 | 81 |
| 2025 | 2 | — | 0 | 51 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Apex Locator is used to detect the apex of root canal. This device must only be used in hospital environments, clinics or dental offices by qualified dental personnel.
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/K242383 · printed Nov 5, 2026
Cite this page
510(k) Report. “K242383: Apex Locator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K242383
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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