510(k) · Cleared
ClearedRoot Apex Locator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Toei Electric Co., Ltd. · LQY Locator, Root Apex
Cleared on Sep 11, 1997 as substantially equivalent to K953867 (J. Morita USA, Inc., 1995) and 1 other predicate after a 77-day review. Its family tree reaches back 1 generation to 1993. 16 later devices descend from it.
- Decided
- Sep 11, 1997
- Review
- 77 days
- Class
- Class U
- Product code
- LQY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K921979 (1993). 2 ancestors in all. 16 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK921979 Root ZXJ. Morita USA, Inc. · 1993
- This deviceK972407 Root Apex LocatorToei Electric Co., Ltd. · 1997
- Descendant · cites it directly · 15 of its ownK022020 Justwo Model Tme-601 Root Apex LocatorToei Electric Co., Ltd. · 2002
- Descendant · 2 generations on · 7 of its ownK032743 Apex NRGMedicnrg, Ltd. · 2004
- Descendant · 2 generations on · 6 of its ownK030526 Pediguard Nerve Detector SystemSpine Vision, Inc. · 2004
- Descendant · 3 generations on · 5 of its ownK123390 Pediguard Nerve Detector SystemSpineguard S.A. · 2013
- Descendant · 3 generations on · 5 of its ownK063843 Apexnrg XFRMedicnrg, Ltd. · 2007
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K022020Justwo Model Tme-601 Root Apex LocatorToei Electric Co., Ltd. · 2002 · cites it directly15descendants
- K032743Apex NRGMedicnrg, Ltd. · 2004 · 2 generations on7descendants
- K030526Pediguard Nerve Detector SystemSpine Vision, Inc. · 2004 · 2 generations on6descendants
- K123390Pediguard Nerve Detector SystemSpineguard S.A. · 2013 · 3 generations on5descendants
- K063843Apexnrg XFRMedicnrg, Ltd. · 2007 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K921979 | Root ZX | J. Morita USA, Inc. | 1993 | — |
| 0 (this device) | K972407 | Root Apex Locator | Toei Electric Co., Ltd. | 1997 | — |
| +1 | K022020 | Justwo Model Tme-601 Root Apex Locator | Toei Electric Co., Ltd. | 2002 | — |
| +2 | K032743 | Apex NRG | Medicnrg, Ltd. | 2004 | — |
| +2 | K030526 | Pediguard Nerve Detector System | Spine Vision, Inc. | 2004 | — |
| +3 | K123390 | Pediguard Nerve Detector System | Spineguard S.A. | 2013 | — |
| +3 | K063843 | Apexnrg XFR | Medicnrg, Ltd. | 2007 | — |
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 |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2021 | 1 | 0 |
| 2023 | 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? (2)
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 |
|---|---|---|---|
| * | K953867 | Root Canal Length Measuring DeviceSummary page 1…N.W. Washington, D.C. 20005 (202) 408-3740 2. Device Information: Root canal length measurement device. This device is not classified. 3. Predicate Device: Root ZX, K953867, K921979 4. Device Description: The subject device is a lightweight, fully-automatic, battery-operated device that allows a den… | 1995 |
| * | K921979 | Root ZXSummary page 1…hington, D.C. 20005 (202) 408-3740 2. Device Information: Root canal length measurement device. This device is not classified. 3. Predicate Device: Root ZX, K953867, K921979 4. Device Description: The subject device is a lightweight, fully-automatic, battery-operated device that allows a dentist or o… | 1993 |
What descends from it? (16)
See all 161 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K022020 | Justwo Model Tme-601 Root Apex Locator | 2002 | 15 |
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?
How does its category compare?
All LQY devicesLQY Locator, Root Apex: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Measurement of the length of the root canal for the purpose of performing root canals and related dental procedures.
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/K972407 · printed Nov 6, 2026
Cite this page
510(k) Report. “K972407: 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/K972407
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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