510(k) · Cleared
ClearedJustwo Model Tme-601 Root 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 Jul 2, 2002 as substantially equivalent to K972407 (Toei Electric Co., Ltd., 1997) after a 12-day review. Its family tree reaches back 2 generations to 1993. 15 later devices descend from it.
- Decided
- Jul 2, 2002
- Review
- 12 days
- Class
- Class U
- Product code
- LQY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K921979 (1993). 3 ancestors in all. 15 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK921979 Root ZXJ. Morita USA, Inc. · 1993
- 1 generation backK972407 Root Apex LocatorToei Electric Co., Ltd. · 1997
- This deviceK022020 Justwo Model Tme-601 Root Apex LocatorToei Electric Co., Ltd. · 2002
- Descendant · cites it directly · 7 of its ownK032743 Apex NRGMedicnrg, Ltd. · 2004
- Descendant · cites it directly · 6 of its ownK030526 Pediguard Nerve Detector SystemSpine Vision, Inc. · 2004
- Descendant · 2 generations on · 5 of its ownK123390 Pediguard Nerve Detector SystemSpineguard S.A. · 2013
- Descendant · 2 generations on · 5 of its ownK063843 Apexnrg XFRMedicnrg, Ltd. · 2007
- Descendant · 2 generations on · 4 of its ownK143159 Cannulated PediGuard Needle#1, Cannulated PediGuard Needle#2…Spineguard S.A. · 2015
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K032743Apex NRGMedicnrg, Ltd. · 2004 · cites it directly7descendants
- K030526Pediguard Nerve Detector SystemSpine Vision, Inc. · 2004 · cites it directly6descendants
- K123390Pediguard Nerve Detector SystemSpineguard S.A. · 2013 · 2 generations on5descendants
- K063843Apexnrg XFRMedicnrg, Ltd. · 2007 · 2 generations on5descendants
- K143159Cannulated PediGuard Needle#1, Cannulated PediGuard Needle#2, Cannulated PediGuard…Spineguard S.A. · 2015 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K921979 | Root ZX | J. Morita USA, Inc. | 1993 | — |
| −1 | K972407 | Root Apex Locator | Toei Electric Co., Ltd. | 1997 | — |
| 0 (this device) | K022020 | Justwo Model Tme-601 Root Apex Locator | Toei Electric Co., Ltd. | 2002 | — |
| +1 | K032743 | Apex NRG | Medicnrg, Ltd. | 2004 | — |
| +1 | K030526 | Pediguard Nerve Detector System | Spine Vision, Inc. | 2004 | — |
| +2 | K123390 | Pediguard Nerve Detector System | Spineguard S.A. | 2013 | — |
| +2 | K063843 | Apexnrg XFR | Medicnrg, Ltd. | 2007 | — |
| +2 | K143159 | Cannulated PediGuard Needle#1, Cannulated PediGuard Needle#2, Cannulated… | Spineguard S.A. | 2015 | — |
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 |
|---|---|---|
| 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 12.1 · 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 |
|---|---|---|---|
| * | K972407 | Root Apex LocatorSummary page 1…moflsual Name: Root Apex Locator This device has not been classified. 2. Equivalent legally marketed device: Toei Electric Co. Ltd “Root Apex Locator” K972407 3. Indications for Use (intended use) The device is for measurement of the length of the root canal for the purpose o… | 1997 |
What descends from it? (15)
See all 152 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 9 years and passes through 2 companies; a new generation was cleared every 4.8 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K032743 (Medicnrg, Ltd., 2004) has gone furthest, with 7 descendants of its own.
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, for use by a trained professional in general dentistry.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022020 · printed Nov 3, 2026
Cite this page
510(k) Report. “K022020: Justwo Model Tme-601 Root 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/K022020
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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