510(k) · Cleared
ClearedApex Locator, DPEX III
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guilin Woodpecker Medical Instrument Co., Ltd. · LQY Locator, Root Apex
Cleared on Dec 18, 2018 as substantially equivalent to K131907 (Dentsply International, Inc., 2014) after a 237-day review. Its family tree reaches back 3 generations to 1999. 2 later devices descend from it.
- Decided
- Dec 18, 2018
- Review
- 237 days
- Class
- Class U
- Product code
- LQY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K992233 (1999). 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK992233 Apex Locator Bingo-1020Dent Corp. Research & Development · 1999
- 2 generations backK111474 Bingo ProForum Engineering Technologies (96), Ltd. · 2011
- 1 generation backK131907 Raypex 6Dentsply International, Inc. · 2014
- This deviceK181087 Apex Locator, DPEX IIIGuilin Woodpecker Medical Instrument Co., Ltd. · 2018
- Descendant · cites it directly · 0 of its ownK252224 Apex Locator (FindPex)Changzhou Sifary Medical Technology Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK231990 Apex LocatorCefla S.C. · 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 |
|---|---|---|---|---|---|
| −3 | K992233 | Apex Locator Bingo-1020 | Dent Corp. Research & Development | 1999 | — |
| −2 | K111474 | Bingo Pro | Forum Engineering Technologies (96), Ltd. | 2011 | — |
| −1 | K131907 | Raypex 6 | Dentsply International, Inc. | 2014 | — |
| 0 (this device) | K181087 | Apex Locator, DPEX III | Guilin Woodpecker Medical Instrument Co., Ltd. | 2018 | — |
| +1 | K252224 | Apex Locator (FindPex) | Changzhou Sifary Medical Technology Co., Ltd. | 2026 | — |
| +1 | K231990 | Apex Locator | Cefla S.C. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K131907 | Raypex 6Summary page 5…Classification Panel: Dental Primary Predicate Device Trade Name: RAYPEX 6 510(k) Reference: K131907 Common Name: Root apex locator Regulation Number: Pre-Amendment… | 2014 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 19 years and passes through 4 companies; a new generation was cleared every 4.9 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K252224 (Changzhou Sifary Medical Technology Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K131907.
How does its category compare?
All LQY devicesLQY Locator, Root Apex: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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, DPEX III is a microprocessor controlled device intended for locating the apex of root canal.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181087 · printed Nov 5, 2026
Cite this page
510(k) Report. “K181087: Apex Locator, DPEX III.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K181087
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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