Ecential Robotics: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Ecential Robotics” (first 2022, latest 2026), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 90 days. Since 2017 the median was 90 days, against 94 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 |
|---|---|---|
| 2022 | 3 | 14 |
| 2023 | 1 | 30 |
| 2024 | 1 | 260 |
| 2025 | 1 | 164 |
| 2026 | 1 | 110 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Ecential Robotics took a median 90 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 94 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OLO | Orthopedic Stereotaxic Instrument | 5 | 5 |
| OWB | Interventional Fluoroscopic X-Ray System | 2 | 2 |
Review panels
- Orthopedic (5)
- Radiology (2)
Most recent Ecential Robotics 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261113 | Op.n Spine Navigation and Robotic Guidance | OLO | 2026-07-22 | 110 |
| K242914 | Op.n(TM) Navigation | OLO | 2025-03-07 | 164 |
| K233228 | Spine Navigation and Robotic-Assistance Device | OLO | 2024-06-14 | 260 |
| K231886 | SURGIVISIO Device | OLO | 2023-07-27 | 30 |
| K221028 | SURGIVISIO Device | OLO | 2022-07-06 | 90 |
| K220946 | SURGIVISIO Device | OWB | 2022-04-15 | 14 |
| K220627 | SURGIVISIO Device | OWB | 2022-03-18 | 14 |
Recalls
openFDA lists no recalls under a recalling firm named Ecential Robotics.
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 Ecential Robotics?
FDA lists 7 510(k) clearances under the applicant name “Ecential Robotics” (first 2022, latest 2026), across 2 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Ecential Robotics?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ecential Robotics is 90 days. Since 2017: 90 days, versus 94 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Ecential Robotics?
The most frequent FDA product codes under this applicant name are OLO (Orthopedic Stereotaxic Instrument, 5); OWB (Interventional Fluoroscopic X-Ray System, 2).
Next steps
- See all 7 Ecential Robotics clearances with predicates and recalls
- Run predicate analysis for product code OLO, Ecential Robotics'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.