Neocis, Inc.: FDA filings under this applicant name
FDA lists 18 510(k) clearances under the applicant name “Neocis, Inc.” (first 2016, latest 2025), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 114 days. Since 2017 the median was 114 days, against 116 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2016 | 1 | 216 |
| 2017 | 0 | — |
| 2018 | 2 | 98 |
| 2019 | 2 | 110 |
| 2020 | 5 | 86 |
| 2021 | 2 | 195 |
| 2022 | 3 | 115 |
| 2023 | 1 | 126 |
| 2024 | 0 | — |
| 2025 | 2 | 103 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Neocis, Inc. took a median 114 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 116 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| PLV | Dental Stereotaxic Instrument | 16 | 16 |
| QRY | Dental Navigation System | 2 | 2 |
Review panels
- Dental (18)
Most recent Neocis, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252376 | Yomi S Robotic System | PLV | 2025-10-28 | 90 |
| K251835 | Yomi Robotic System | PLV | 2025-10-10 | 116 |
| K231018 | Yomi Robotic System | PLV | 2023-08-14 | 126 |
| K222750 | Yomi Robotic System | QRY | 2022-12-08 | 87 |
| K222049 | Yomi Robotic System | QRY | 2022-11-04 | 115 |
| K211466 | Yomi Robotic System with YomiPlan Go | PLV | 2022-06-14 | 399 |
| K210711 | Neocis Guidance System (NGS) with Yomi Plan v2.0.1 | PLV | 2021-12-22 | 287 |
| K211129 | Neocis Guidance System (NGS) with Intraoral Fiducial Array | PLV | 2021-07-28 | 103 |
| K203401 | Neocis Guidance System (NGS) with Patient Splints (EPS) | PLV | 2020-12-15 | 26 |
| K202264 | Neocis Guidance System (NGS) with Yomi Plan v2.0 | PLV | 2020-12-04 | 115 |
8 earlier clearances. See the full list in Caduvo.
Recalls
5 product recalls in 3 recall events; 0 initiated in the last five years. Most recent: 2020-10-30.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Neocis, Inc.?
FDA lists 18 510(k) clearances under the applicant name “Neocis, Inc.” (first 2016, latest 2025), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Neocis, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Neocis, Inc. is 114 days. Since 2017: 114 days, versus 116 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Neocis, Inc.?
The most frequent FDA product codes under this applicant name are PLV (Dental Stereotaxic Instrument, 16); QRY (Dental Navigation System, 2).
Next steps
- See all 18 Neocis, Inc. clearances with predicates and recalls
- Run predicate analysis for product code PLV, Neocis, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.