Medrobotics Corporation: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Medrobotics Corporation” (first 2015, latest 2018), across 3 product codes in 3 review panels. Median 510(k) review time under this name: 125 days. Since 2017 the median was 186 days, against 175 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 |
|---|---|---|
| 2015 | 1 | 115 |
| 2016 | 0 | — |
| 2017 | 3 | 246 |
| 2018 | 1 | 125 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Medrobotics Corporation took a median 186 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 175 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EOB | Nasopharyngoscope (Flexible Or Rigid) | 2 | 2 |
| FDF | Colonoscope And Accessories, Flexible/Rigid | 2 | 2 |
| HET | Laparoscope, Gynecologic (And Accessories) | 1 | 1 |
Review panels
Most recent Medrobotics Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K172796 | Flex Robotic System and Flex Transabdominal Drive | HET | 2018-01-18 | 125 |
| K170453 | Medrobotics Flex Robotic System | EOB | 2017-10-19 | 246 |
| K172036 | Medrobotics Flex Robotic System | FDF | 2017-08-03 | 29 |
| K162330 | Flex Robotic System and Flex Colorectal Drive | FDF | 2017-05-04 | 258 |
| K150776 | Medrobotics Flex System | EOB | 2015-07-17 | 115 |
Recalls
2 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2019-01-25.
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 Medrobotics Corporation?
FDA lists 5 510(k) clearances under the applicant name “Medrobotics Corporation” (first 2015, latest 2018), across 3 product codes in 3 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 Medrobotics Corporation?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medrobotics Corporation is 125 days. Since 2017: 186 days, versus 175 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Medrobotics Corporation?
The most frequent FDA product codes under this applicant name are EOB (Nasopharyngoscope (Flexible Or Rigid), 2); FDF (Colonoscope And Accessories, Flexible/Rigid, 2); HET (Laparoscope, Gynecologic (And Accessories), 1).
Next steps
- See all 5 Medrobotics Corporation clearances with predicates and recalls
- Run predicate analysis for product code EOB, Medrobotics Corporation'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.