510(k) · Cleared
ClearedApex NRG
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 Mar 15, 2004 as substantially equivalent to K022020 (Toei Electric Co., Ltd., 2002) and 1 other predicate after a 193-day review. Its family tree reaches back 3 generations to 1993. 7 later devices descend from it.
- Decided
- Mar 15, 2004
- Review
- 193 days
- Class
- Class U
- Product code
- LQY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K921979 (1993). 4 ancestors in all. 7 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK921979 Root ZXJ. Morita USA, Inc. · 1993
- 2 generations backK972407 Root Apex LocatorToei Electric Co., Ltd. · 1997
- 1 generation backK022020 Justwo Model Tme-601 Root Apex LocatorToei Electric Co., Ltd. · 2002
- This deviceK032743 Apex NRGMedicnrg, Ltd. · 2004
- Descendant · cites it directly · 5 of its ownK063843 Apexnrg XFRMedicnrg, Ltd. · 2007
- Descendant · cites it directly · 4 of its ownK071133 Apexnrg-Blue Electronic Apex LocatorMedicnrg, Ltd. · 2007
- Descendant · 2 generations on · 1 of its ownK090598 Cariescan ProCariescan, Ltd. · 2009
- Descendant · 2 generations on · 1 of its ownK080113 Apex Dal Electronic Apex LocatorMedicnrg, Ltd. · 2008
- Descendant · 3 generations on · 0 of its ownK170822 Electronic Caries DetectorOrtek Therapeutics, Inc. · 2017
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K063843Apexnrg XFRMedicnrg, Ltd. · 2007 · cites it directly5descendants
- K071133Apexnrg-Blue Electronic Apex LocatorMedicnrg, Ltd. · 2007 · cites it directly4descendants
- K090598Cariescan ProCariescan, Ltd. · 2009 · 2 generations on1descendant
- K080113Apex Dal Electronic Apex LocatorMedicnrg, Ltd. · 2008 · 2 generations on1descendant
- K170822Electronic Caries DetectorOrtek Therapeutics, Inc. · 2017 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K921979 | Root ZX | J. Morita USA, Inc. | 1993 | — |
| −2 | K972407 | Root Apex Locator | Toei Electric Co., Ltd. | 1997 | — |
| −1 | K022020 | Justwo Model Tme-601 Root Apex Locator | Toei Electric Co., Ltd. | 2002 | — |
| 0 (this device) | K032743 | Apex NRG | Medicnrg, Ltd. | 2004 | — |
| +1 | K063843 | Apexnrg XFR | Medicnrg, Ltd. | 2007 | — |
| +1 | K071133 | Apexnrg-Blue Electronic Apex Locator | Medicnrg, Ltd. | 2007 | — |
| +2 | K090598 | Cariescan Pro | Cariescan, Ltd. | 2009 | — |
| +2 | K080113 | Apex Dal Electronic Apex Locator | Medicnrg, Ltd. | 2008 | — |
| +3 | K170822 | Electronic Caries Detector | Ortek Therapeutics, Inc. | 2017 | — |
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 |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2017 | 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 |
|---|---|---|---|
| * | K022020 | Justwo Model Tme-601 Root Apex LocatorSummary page 2…ice Applicant Name 510(k) Classification Name Number JUSTWO TME-601 Toei Electric Co, K022020 unclassified Root Apex Locator POBox 7007 Deerfield, IL 60015 ROOT ZX… | 2002 |
| * | K921979 | Root ZXSummary page 2…, K022020 unclassified Root Apex Locator POBox 7007 Deerfield, IL 60015 ROOT ZX J. Morita USA, Inc. K921979 unclassified 9 Mason Irvine, CA 92618 Additional Substantial Equiva… | 1993 |
What descends from it? (7)
3 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 11 years and passes through 3 companies; a new generation was cleared every 4.3 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K063843 (Medicnrg, Ltd., 2007) has gone furthest, with 5 descendants of its own.
- 1 other device also cites its predicate K022020.
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/K032743 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032743: Apex NRG.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032743
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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