510(k) · Cleared
ClearedRoot Apex Locator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Foshan Coxo Medical Instrument Co., Ltd. · LQY Locator, Root Apex
Cleared on Jul 20, 2022 as substantially equivalent to K203836 (Changzhou Bomedent Medical Technology Co.,Ltd, 2021) after a 373-day review. Its family tree reaches back 5 generations to 1999. 1 later device descends from it.
- Decided
- Jul 20, 2022
- Review
- 373 days
- Class
- Class U
- Product code
- LQY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K992233 (1999). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK992233 Apex Locator Bingo-1020Dent Corp. Research & Development · 1999
- 4 generations backK111474 Bingo ProForum Engineering Technologies (96), Ltd. · 2011
- 3 generations backK131907 Raypex 6Dentsply International, Inc. · 2014
- 2 generations backK191806 Propex IQ Apex LocatorDentsply Sirona · 2019
- 1 generation backK203836 BOMEDENT Apex locator, WISMY Apex locatorChangzhou Bomedent Medical Technology Co.,Ltd · 2021
- This deviceK212178 Root Apex LocatorFoshan Coxo Medical Instrument Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK242383 Apex LocatorShenzhen Rogin Medical Co., Ltd. · 2025
Most influential descendants
Showing 1 of 1 · See all- K242383Apex LocatorShenzhen Rogin Medical Co., Ltd. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K992233 | Apex Locator Bingo-1020 | Dent Corp. Research & Development | 1999 | — |
| −4 | K111474 | Bingo Pro | Forum Engineering Technologies (96), Ltd. | 2011 | — |
| −3 | K131907 | Raypex 6 | Dentsply International, Inc. | 2014 | — |
| −2 | K191806 | Propex IQ Apex Locator | Dentsply Sirona | 2019 | — |
| −1 | K203836 | BOMEDENT Apex locator, WISMY Apex locator | Changzhou Bomedent Medical Technology Co.,Ltd | 2021 | — |
| 0 (this device) | K212178 | Root Apex Locator | Foshan Coxo Medical Instrument Co., Ltd. | 2022 | — |
| +1 | K242383 | Apex Locator | Shenzhen Rogin Medical Co., Ltd. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 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 |
|---|---|---|---|
| * | K203836 | BOMEDENT Apex locator, WISMY Apex locatorSummary page 5…anal files that can be used with the Root Apex Locator C-ROOT I is Nickel titanium (NiTi). 5. Identification of Predicate Device(s) Predicate Device K203836 BOMEDENT Apex locator ChangZhou BoMedent Medical Technology Co.,Ltd Reference Device: 510(k) Number: K20199… | 2021 |
| † | K201993 | E-connect S Endo Motor with built-in Apex Locator | 2021 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K242383 | Apex Locator | 2025 | 0 |
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 23 years and passes through 6 companies; a new generation was cleared every 2.2 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K242383 (Shenzhen Rogin Medical Co., Ltd., 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K203836.
How does its category compare?
All LQY devicesLQY Locator, Root Apex: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
The Root Apex Locator is used to detect the apex ofroot canal.This device must only be used in hospital environments,
clinics or dental offices by qualified dental personnel.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212178 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212178: Root Apex Locator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212178
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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