510(k) · Cleared
ClearedRoot ZX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
J. Morita USA, Inc. · LQY Locator, Root Apex
Cleared on May 27, 1993 after a 394-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 24 later devices descend from it.
- Decided
- May 27, 1993
- Review
- 394 days
- Class
- Class U
- Product code
- LQY
- Recalls
- None
- Predicates
- 0
24 later devices descend from it, 5 citing it directly.
- This deviceK921979 Root ZXJ. Morita USA, Inc. · 1993
- Descendant · cites it directly · 16 of its ownK972407 Root Apex LocatorToei Electric Co., Ltd. · 1997
- Descendant · 2 generations on · 15 of its ownK022020 Justwo Model Tme-601 Root Apex LocatorToei Electric Co., Ltd. · 2002
- Descendant · cites it directly · 7 of its ownK032743 Apex NRGMedicnrg, Ltd. · 2004
- Descendant · 3 generations on · 6 of its ownK030526 Pediguard Nerve Detector SystemSpine Vision, Inc. · 2004
- Descendant · 4 generations on · 5 of its ownK123390 Pediguard Nerve Detector SystemSpineguard S.A. · 2013
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K972407Root Apex LocatorToei Electric Co., Ltd. · 1997 · cites it directly16descendants
- K022020Justwo Model Tme-601 Root Apex LocatorToei Electric Co., Ltd. · 2002 · 2 generations on15descendants
- K032743Apex NRGMedicnrg, Ltd. · 2004 · cites it directly7descendants
- K030526Pediguard Nerve Detector SystemSpine Vision, Inc. · 2004 · 3 generations on6descendants
- K123390Pediguard Nerve Detector SystemSpineguard S.A. · 2013 · 4 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K921979 | Root ZX | J. Morita USA, Inc. | 1993 | — |
| +1 | K972407 | Root Apex Locator | Toei Electric Co., Ltd. | 1997 | — |
| +2 | K022020 | Justwo Model Tme-601 Root Apex Locator | Toei Electric Co., Ltd. | 2002 | — |
| +1 | K032743 | Apex NRG | Medicnrg, Ltd. | 2004 | — |
| +3 | K030526 | Pediguard Nerve Detector System | Spine Vision, Inc. | 2004 | — |
| +4 | K123390 | Pediguard Nerve Detector System | Spineguard S.A. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (24)
See all 245 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?
- Of its descendants, K972407 (Toei Electric Co., Ltd., 1997) has gone furthest, with 16 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 | — |
https://510kreport.com/device/K921979 · printed Nov 6, 2026
Cite this page
510(k) Report. “K921979: Root ZX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K921979
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026