510(k) · Cleared
ClearedYomi Robotic System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neocis, Inc. · PLV Dental Stereotaxic Instrument
Cleared on Oct 10, 2025 as substantially equivalent to K231018 (Neocis, Inc., 2023) after a 116-day review. Its family tree reaches back 9 generations to 1999.
- Decided
- Oct 10, 2025
- Review
- 116 days
- Class
- Class II
- Product code
- PLV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K983831 (1999). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 9 generations backK983831 VECTORVISION2Brainlab AG · 1999
- 5 generations between
- 3 generations backK222049 Yomi Robotic SystemNeocis, Inc. · 2022
- 2 generations backK222750 Yomi Robotic SystemNeocis, Inc. · 2022
- 1 generation backK231018 Yomi Robotic SystemNeocis, Inc. · 2023
- This deviceK251835 Yomi Robotic SystemNeocis, Inc. · 2025
Show all 9 generations
- Root · 9 generations backK983831 VECTORVISION2Brainlab AG · 1999
- 8 generations backK023424 Igi-SystemDenx Advanced Dental Systems · 2003
- 7 generations backK150222 X-Guide Surgical Navigation SystemX-Nav Technologies, LLC · 2015 · Recalled
- 6 generations backK161399 Neocis Guidance SystemNeocis, Inc. · 2016 · Recalled
- 5 generations backK202264 Neocis Guidance System (NGS) with Yomi Plan v2.0Neocis, Inc. · 2020
- 4 generations backK210711 Neocis Guidance System (NGS) with Yomi Plan v2.0.1Neocis, Inc. · 2021
- 3 generations backK222049 Yomi Robotic SystemNeocis, Inc. · 2022
- 2 generations backK222750 Yomi Robotic SystemNeocis, Inc. · 2022
- 1 generation backK231018 Yomi Robotic SystemNeocis, Inc. · 2023
- This deviceK251835 Yomi Robotic SystemNeocis, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K983831 | VECTORVISION2 | Brainlab AG | 1999 | — |
| −8 | K023424 | Igi-System | Denx Advanced Dental Systems | 2003 | — |
| −7 | K150222 | X-Guide Surgical Navigation System | X-Nav Technologies, LLC | 2015 | 1 |
| −6 | K161399 | Neocis Guidance System | Neocis, Inc. | 2016 | 1 |
| −5 | K202264 | Neocis Guidance System (NGS) with Yomi Plan v2.0 | Neocis, Inc. | 2020 | — |
| −4 | K210711 | Neocis Guidance System (NGS) with Yomi Plan v2.0.1 | Neocis, Inc. | 2021 | — |
| −3 | K222049 | Yomi Robotic System | Neocis, Inc. | 2022 | — |
| −2 | K222750 | Yomi Robotic System | Neocis, Inc. | 2022 | — |
| −1 | K231018 | Yomi Robotic System | Neocis, Inc. | 2023 | — |
| 0 (this device) | K251835 | Yomi Robotic System | Neocis, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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 PLV? 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 PLV device
- #1 K231018 Yomi Robotic Systemscore 13.9 · 8 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 |
|---|---|---|---|
| * | K231018 | Yomi Robotic SystemSummary page 5…instrument and accessories (21 CFR 872.4120) Classification: Class II Product Code: PLV, QRY Predicate Devices Primary Predicate: Yomi Robotic System (K231018) Reference Device: Relu Creator (K233925) Indications for Use The Yomi Robotic System (Yomi) is a computerized robotic navigatio… | 2023 |
| † | K233925 | Relu Creator | 2024 |
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 26 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 2 of the 10 ancestors have a recall of any class.
- 1 other device also cites its predicate K231018.
How does its category compare?
All PLV devicesPLV Dental Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · PLV
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PLV
399in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PLV
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PLV
6in 2025
MAUDE reports naming product code PLV, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 2 | — | 0 | 0 |
| 2019 | 2 | — | 1 | 3 |
| 2020 | 7 | 86 | 1 | 0 |
| 2021 | 2 | — | 0 | 11 |
| 2022 | 3 | 399 | 0 | 39 |
| 2023 | 1 | — | 0 | 15 |
| 2024 | 1 | — | 0 | 9 |
| 2025 | 2 | — | 0 | 6 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Yomi Robotic System (Yomi) is a computerized robotic navigational system intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery. The system provides software to preoperatively plan dental implantation procedures and provides robotic navigational guidance of the surgical instruments. The system can also be used for planning and performing guided bone reduction (also…
Read the full statement (140 words)
The Yomi Robotic System (Yomi) is a computerized robotic navigational system intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery. The system provides software to preoperatively plan dental implantation procedures and provides robotic navigational guidance of the surgical instruments. The system can also be used for planning and performing guided bone reduction (also known as alveoplasty) of the mandible and/or maxilla. Yomi is intended for use in partially edentulous and fully edentulous adult patients who qualify for dental implants.
When YomiPlan software is used for preplanning on third party PCs, it is intended to perform the planning (pre-operative) phase of dental implantation surgery. Yomi Plan provides pre-operative planning for dental implantation procedures using the Yomi Robotic System. The output of Yomi Plan is to be used with the Yomi Robotic System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251835 · printed Nov 4, 2026
Cite this page
510(k) Report. “K251835: Yomi Robotic System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K251835
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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