510(k) · Cleared
ClearedApex Locator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cefla S.C. · LQY Locator, Root Apex
Cleared on Feb 13, 2024 as substantially equivalent to K181087 (Guilin Woodpecker Medical Instrument Co., Ltd., 2018) after a 223-day review. Its family tree reaches back 4 generations to 1999.
- Decided
- Feb 13, 2024
- Review
- 223 days
- Class
- Class U
- Product code
- LQY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K992233 (1999). No later device cites it as a predicate yet.
- Root · 4 generations backK992233 Apex Locator Bingo-1020Dent Corp. Research & Development · 1999
- 3 generations backK111474 Bingo ProForum Engineering Technologies (96), Ltd. · 2011
- 2 generations backK131907 Raypex 6Dentsply International, Inc. · 2014
- 1 generation backK181087 Apex Locator, DPEX IIIGuilin Woodpecker Medical Instrument Co., Ltd. · 2018
- This deviceK231990 Apex LocatorCefla S.C. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K992233 | Apex Locator Bingo-1020 | Dent Corp. Research & Development | 1999 | — |
| −3 | K111474 | Bingo Pro | Forum Engineering Technologies (96), Ltd. | 2011 | — |
| −2 | K131907 | Raypex 6 | Dentsply International, Inc. | 2014 | — |
| −1 | K181087 | Apex Locator, DPEX III | Guilin Woodpecker Medical Instrument Co., Ltd. | 2018 | — |
| 0 (this device) | K231990 | Apex Locator | Cefla S.C. | 2024 | — |
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 |
|---|---|---|---|
| * | K181087 | Apex Locator, DPEX IIISummary page 6…igh-Tech Zone Guilin City, CN 541004Owner/Operator: W&H Establishment Operations: Manufacturer 510 (k): K181087 Device Name: APEX LOCATOR DPEX III Applicant: Guilin Woodpecker Medical Instrument C… | 2018 |
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 25 years and passes through 5 companies; a new generation was cleared every 5.2 years on median.
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K181087.
How does its category compare?
All LQY devicesLQY Locator, Root Apex: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 a device intended for locating the apex of the root canal during endodontic treatments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231990 · printed Nov 3, 2026
Cite this page
510(k) Report. “K231990: Apex Locator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K231990
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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