Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
OTU Medical, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
125 daysmedian FDA review time
273 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K231702 | WiScope® Digital Cystoscope System, WiScope® Single-Use Digi | OTU Medical, Inc. | 2023-09-29 | 109 | 0 |
| K220399 | WiScope Digital Bronchoscope System, WiScope Single-Use Digi | OTU Medical, Inc. | 2022-06-16 | 125 | 0 |
| K212202 | WiScope Digital Cystoscope System, WiScope Single-Use Digita | OTU Medical, Inc. | 2022-04-13 | 273 | 0 |
| K210579 | WiScope OM Endoscope System, WiScope Single-Use Digital Flex | OTU Medical, Inc. | 2021-07-22 | 146 | 0 |
| K181977 | WiScope Digital Endoscope System | OTU Medical, Inc. | 2018-08-14 | 21 | 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