Innocare Optoelectronics Corp.: FDA clearances and approvals
Innocare Optoelectronics Corp. has 6 FDA 510(k) clearances (first 2019, latest 2025), across 1 product code in 1 review panel. Median 510(k) review time: 66 days. Since 2017 its median was 66 days, against 30 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2019 | 1 | 41 |
| 2020 | 1 | 125 |
| 2021 | 1 | 20 |
| 2022 | 1 | 51 |
| 2023 | 0 | — |
| 2024 | 1 | 80 |
| 2025 | 1 | 179 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Innocare Optoelectronics Corp.'s cleared 510(k)s took a median 66 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 30 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | 6 | 6 |
Review panels
- Radiology (6)
Most recent Innocare Optoelectronics Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K250211 | Yushan X-Ray Flat Panel Detector | MQB | 2025-07-22 | 179 |
| K243171 | Yushan X-Ray Flat Panel Detector | MQB | 2024-12-19 | 80 |
| K220510 | Yushan X-Ray Flat Panel Detector with DROC | MQB | 2022-04-14 | 51 |
| K210988 | Yushan X-Ray Flat Panel Detector with DROC | MQB | 2021-04-21 | 20 |
| K201528 | Yushan X-Ray Flat Panel Detector with DROC | MQB | 2020-10-11 | 125 |
| K191939 | Yushan X-Ray Flat Panel Detector | MQB | 2019-08-29 | 41 |
Recalls
openFDA lists no recalls under a recalling firm named Innocare Optoelectronics Corp..
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 Innocare Optoelectronics Corp. have?
Innocare Optoelectronics Corp. has 6 FDA 510(k) clearances (first 2019, latest 2025), across 1 product code in 1 review panel.
How long does FDA take to clear Innocare Optoelectronics Corp.'s 510(k)s?
The median time from FDA receipt to decision across Innocare Optoelectronics Corp.'s cleared 510(k)s is 66 days. Since 2017: 66 days, versus 30 days for all cleared 510(k)s in the same product codes.
What devices does Innocare Optoelectronics Corp. make?
Its most frequent FDA product codes are MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager), 6).
Has Innocare Optoelectronics Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Innocare Optoelectronics Corp. Related entities may recall under other names.
Next steps
- See all 6 Innocare Optoelectronics Corp. clearances with predicates and recalls
- Run predicate analysis for product code MQB, Innocare Optoelectronics Corp.'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.