OTU Medical, Inc.: FDA clearances and approvals
OTU Medical, Inc. has 5 FDA 510(k) clearances (first 2018, latest 2023), across 3 product codes in 2 review panels. Median 510(k) review time: 125 days. Since 2017 its median was 125 days, against 146 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2018 | 1 | 21 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 146 |
| 2022 | 2 | 199 |
| 2023 | 1 | 109 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, OTU Medical, Inc.'s cleared 510(k)s took a median 125 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 146 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FAJ | Cystoscope And Accessories, Flexible/Rigid | 2 | 2 |
| FGB | Ureteroscope And Accessories, Flexible/Rigid | 2 | 2 |
| EOQ | Bronchoscope (Flexible Or Rigid) | 1 | 1 |
Review panels
Most recent OTU Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K231702 | WiScope® Digital Cystoscope System, WiScope® Single-Use Digital Flexible Cystoscope, WiScope® Medical Tablet | FAJ | 2023-09-29 | 109 |
| K220399 | WiScope Digital Bronchoscope System, WiScope Single-Use Digital Flexible Bronchoscope, WiScope Image System | EOQ | 2022-06-16 | 125 |
| K212202 | WiScope Digital Cystoscope System, WiScope Single-Use Digital Flexible Cystoscope, WiScope Image System | FAJ | 2022-04-13 | 273 |
| K210579 | WiScope OM Endoscope System, WiScope Single-Use Digital Flexible Ureteroscope.Choledochoscope, WiScope Image System | FGB | 2021-07-22 | 146 |
| K181977 | WiScope Digital Endoscope System | FGB | 2018-08-14 | 21 |
Recalls
openFDA lists no recalls under a recalling firm named OTU Medical, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does OTU Medical, Inc. have?
OTU Medical, Inc. has 5 FDA 510(k) clearances (first 2018, latest 2023), across 3 product codes in 2 review panels.
How long does FDA take to clear OTU Medical, Inc.'s 510(k)s?
The median time from FDA receipt to decision across OTU Medical, Inc.'s cleared 510(k)s is 125 days. Since 2017: 125 days, versus 146 days for all cleared 510(k)s in the same product codes.
What devices does OTU Medical, Inc. make?
Its most frequent FDA product codes are FAJ (Cystoscope And Accessories, Flexible/Rigid, 2); FGB (Ureteroscope And Accessories, Flexible/Rigid, 2); EOQ (Bronchoscope (Flexible Or Rigid), 1).
Has OTU Medical, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching OTU Medical, Inc. Related entities may recall under other names.
Next steps
- See all 5 OTU Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FAJ, OTU Medical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.