510(k) · Cleared
ClearedDr’s Finder NEO
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Good Doctors Co., Ltd. · LQY Locator, Root Apex
Cleared on Mar 30, 2018 as substantially equivalent to K151274 (Good Doctors Co., Ltd., 2016) and 1 other predicate after a 281-day review. Its family tree reaches back 8 generations to 1995.
- Decided
- Mar 30, 2018
- Review
- 281 days
- Class
- Class U
- Product code
- LQY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K951425 (1995). 16 ancestors in all, the oldest K921979 (1993). No later device cites it as a predicate yet.
- Root · 8 generations backK951425 Spectrum Curing Light Polymerization UnitDentsply Intl. · 1995
- 7 generations backK982318 Spectrum 800 Curing UnitDentsply Intl. · 1998
- 6 generations backK031615 Sled Curing Light SystemDentsply International · 2003
- 5 generations backK041372 Smartlite PS Pen-Style Led Curing LightDentsply International · 2004
- 4 generations backK063529 Pencure, Model VL-7J. Morita USA, Inc. · 2007
- 3 generations backK071190 Root ZX IIJ. Morita USA, Inc. · 2007
- 2 generations backK090925 Multiple (Apex Locator), Model RCM-7J. Morita USA, Inc. · 2009
- 1 generation backK151274 Dr's FinderGood Doctors Co., Ltd. · 2016
- This deviceK171867 Dr’s Finder NEOGood Doctors Co., Ltd. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K951425 | Spectrum Curing Light Polymerization Unit | Dentsply Intl. | 1995 | — |
| −7 | K982318 | Spectrum 800 Curing Unit | Dentsply Intl. | 1998 | — |
| −6 | K031615 | Sled Curing Light System | Dentsply International | 2003 | — |
| −5 | K041372 | Smartlite PS Pen-Style Led Curing Light | Dentsply International | 2004 | — |
| −4 | K063529 | Pencure, Model VL-7 | J. Morita USA, Inc. | 2007 | — |
| −3 | K071190 | Root ZX II | J. Morita USA, Inc. | 2007 | — |
| −2 | K090925 | Multiple (Apex Locator), Model RCM-7 | J. Morita USA, Inc. | 2009 | — |
| −1 | K151274 | Dr's Finder | Good Doctors Co., Ltd. | 2016 | — |
| 0 (this device) | K171867 | Dr’s Finder NEO | Good Doctors Co., Ltd. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2009 | 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 |
|---|---|---|---|
| * | K151274 | Dr's FinderSummary page 4…lassification: Unclassified (Pre-Amendment) Product Code: LQY 4. Predicate Device Primary Predicate Device: Dr’s Finder by Good Doctors Co., Ltd. (K151274) Reference Device: Multiple (Apex Locator), Model RCM-7 by J. MRITAMFG. CORP (K090925) 5. Description: The de… | 2016 |
| * | K090925 | Multiple (Apex Locator), Model RCM-7Summary page 4…mary Predicate Device: Dr’s Finder by Good Doctors Co., Ltd. (K151274) Reference Device: Multiple (Apex Locator), Model RCM-7 by J. MRITAMFG. CORP (K090925) 5. Description: The device allows the relative position of a dental file and the apex to be determined electrically. Usi… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
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 23 years and passes through 4 companies; a new generation was cleared every 2.5 years on median.
- None of the 16 ancestors has a recall.
How does its category compare?
All LQY devicesLQY Locator, Root Apex: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
Dr’s Finder NEO is intended for detecting the apex of root canal.
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/K171867 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171867: Dr’s Finder NEO.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171867
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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