Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
PLV — Predicate Candidate Screening
23 FDA 510(k) clearances under this product code; the 50 most recent screened below.
116 daysmedian FDA review time
287 days90th percentile
23clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252376 | Yomi S Robotic System | Neocis, Inc. | 2025-10-28 | 90 | 0 |
| K251835 | Yomi Robotic System | Neocis, Inc. | 2025-10-10 | 116 | 0 |
| K233563 | Navident | Claronav, Inc. | 2024-07-25 | 262 | 0 |
| K231018 | Yomi Robotic System | Neocis, Inc. | 2023-08-14 | 126 | 0 |
| K210947 | Navident | Claronav, Inc. | 2022-06-27 | 454 | 0 |
| K211466 | Yomi Robotic System with YomiPlan Go | Neocis, Inc. | 2022-06-14 | 399 | 0 |
| K213392 | INLIANT Surgical Navigation System | Navigate Surgical Technologies, Inc. | 2022-02-22 | 130 | 0 |
| K210711 | Neocis Guidance System (NGS) with Yomi Plan v2.0.1 | Neocis, Inc. | 2021-12-22 | 287 | 0 |
| K211129 | Neocis Guidance System (NGS) with Intraoral Fiducial Array | Neocis, Inc. | 2021-07-28 | 103 | 0 |
| K203401 | Neocis Guidance System (NGS) with Patient Splints (EPS) | Neocis, Inc. | 2020-12-15 | 26 | 0 |
| K202264 | Neocis Guidance System (NGS) with Yomi Plan v2.0 | Neocis, Inc. | 2020-12-04 | 115 | 0 |
| K202100 | Neocis Guidance System (NGS) with Clamped Chairside Patient | Neocis, Inc. | 2020-10-19 | 82 | 0 |
| K200805 | Neocis Guidance System (NGS) with Patient Splints | Neocis, Inc. | 2020-07-28 | 123 | 0 |
| K200662 | X-Guide® Surgical Navigation System | X-Nav Technologies, LLC | 2020-05-21 | 69 | 0 |
| K200348 | Neocis Guidance System (NGS) with Fiducial Array Splint (FAS | Neocis, Inc. | 2020-05-08 | 86 | 0 |
| K192579 | X-Guide Surgical Navigation System | X-Nav Technologies, LLC | 2020-02-03 | 137 | 0 |
| K191363 | Neocis Planning Software Application (NPSA) for 3rd Party PC | Neocis, Inc. | 2019-10-02 | 133 | 0 |
| K191605 | Neocis Guidance System (NGS) | Neocis, Inc. | 2019-09-11 | 86 | 0 |
| K182776 | Neocis Guidance System | Neocis, Inc. | 2018-12-21 | 81 | 0 |
| K173402 | Neocis Guidance System (NGS) with Chairside Splint | Neocis, Inc. | 2018-02-22 | 114 | 0 |
| K161399 | Neocis Guidance System | Neocis, Inc. | 2016-12-22 | 216 | 0 |
| K161406 | Navident | Claronav, Inc. | 2016-09-08 | 111 | 0 |
| K150222 | X-Guide Surgical Navigation System | X-Nav Technologies, LLC | 2015-10-08 | 251 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda