510(k) · Cleared
ClearedApex Dal Electronic Apex Locator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medicnrg, Ltd. · LQY Locator, Root Apex
Cleared on Feb 15, 2008 as substantially equivalent to K071133 (Medicnrg, Ltd., 2007) after a 30-day review. Its family tree reaches back 6 generations to 1993. 1 later device descends from it.
- Decided
- Feb 15, 2008
- Review
- 30 days
- Class
- Class U
- Product code
- LQY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K921979 (1993). 7 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK921979 Root ZXJ. Morita USA, Inc. · 1993
- 5 generations backK972407 Root Apex LocatorToei Electric Co., Ltd. · 1997
- 4 generations backK022020 Justwo Model Tme-601 Root Apex LocatorToei Electric Co., Ltd. · 2002
- 3 generations backK032743 Apex NRGMedicnrg, Ltd. · 2004
- 2 generations backK063843 Apexnrg XFRMedicnrg, Ltd. · 2007
- 1 generation backK071133 Apexnrg-Blue Electronic Apex LocatorMedicnrg, Ltd. · 2007
- This deviceK080113 Apex Dal Electronic Apex LocatorMedicnrg, Ltd. · 2008
- Descendant · cites it directly · 0 of its ownK101177 Apexnrg RiderMedicnrg, Ltd. · 2010
Most influential descendants
Showing 1 of 1 · See all- K101177Apexnrg RiderMedicnrg, Ltd. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K921979 | Root ZX | J. Morita USA, Inc. | 1993 | — |
| −5 | K972407 | Root Apex Locator | Toei Electric Co., Ltd. | 1997 | — |
| −4 | K022020 | Justwo Model Tme-601 Root Apex Locator | Toei Electric Co., Ltd. | 2002 | — |
| −3 | K032743 | Apex NRG | Medicnrg, Ltd. | 2004 | — |
| −2 | K063843 | Apexnrg XFR | Medicnrg, Ltd. | 2007 | — |
| −1 | K071133 | Apexnrg-Blue Electronic Apex Locator | Medicnrg, Ltd. | 2007 | — |
| 0 (this device) | K080113 | Apex Dal Electronic Apex Locator | Medicnrg, Ltd. | 2008 | — |
| +1 | K101177 | Apexnrg Rider | Medicnrg, Ltd. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 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 |
|---|---|---|---|
| * | K071133 | Apexnrg-Blue Electronic Apex LocatorSummary page 1…tor, Root, Apex Class 2, Product Code LOY, unclassified Name: Apex DAL (Apex Loi::ator) 3. Predicate Device: MedicNRG Blue Api.x Locator (K071133) Earlier devices are: MedicNRG XFG ElEctronic Apex Locator (K063843) &… | 2007 |
| † | K063843 | Apexnrg XFR | 2007 |
| † | K032743 | Apex NRG | 2004 |
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 |
|---|---|---|---|
| K101177 | Apexnrg Rider | 2010 | 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 15 years and passes through 3 companies; a new generation was cleared every 2.8 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K101177 (Medicnrg, Ltd., 2010) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K071133.
How does its category compare?
All LQY devicesLQY Locator, Root Apex: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 Apex DAL is indicated for the measurement of the length of the root canals and related dental procedures, for use by a trained professional in general dentistry.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080113 · printed Nov 4, 2026
Cite this page
510(k) Report. “K080113: Apex Dal Electronic Apex Locator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K080113
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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