Integrated Display Technology, Ltd.: FDA clearances and approvals
Integrated Display Technology, Ltd. has 5 FDA 510(k) clearances (first 1985, latest 1995), across 3 product codes in 3 review panels. Median 510(k) review time: 180 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 3 | 3 |
| FCI | Punch, Biopsy | 1 | 1 |
| FLL | Continuous Measurement Thermometer | 1 | 1 |
Review panels
Most recent Integrated Display Technology, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K951977 | DIGITAL BLOOD PRESSURE METER - MODEL NO.: BPM883 | DXN | 1995-10-24 | 180 |
| K941490 | BLOOD PRESSURE METER MODEL NO. BPM888 | DXN | 1994-11-29 | 246 |
| K942336 | AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR | DXN | 1994-11-28 | 196 |
| K894627 | BT-338N ELECTRONIC CLINICAL THERMOMETER | FCI | 1989-10-23 | 91 |
| K853130 | INTEGRATED DISPLAY TECHNOLOGY LTD. | FLL | 1985-11-08 | 105 |
Recalls
openFDA lists no recalls under a recalling firm named Integrated Display Technology, Ltd..
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 Integrated Display Technology, Ltd. have?
Integrated Display Technology, Ltd. has 5 FDA 510(k) clearances (first 1985, latest 1995), across 3 product codes in 3 review panels.
How long does FDA take to clear Integrated Display Technology, Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Integrated Display Technology, Ltd.'s cleared 510(k)s is 180 days.
What devices does Integrated Display Technology, Ltd. make?
Its most frequent FDA product codes are DXN (System, Measurement, Blood-Pressure, Non-Invasive, 3); FCI (Punch, Biopsy, 1); FLL (Continuous Measurement Thermometer, 1).
Has Integrated Display Technology, Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Integrated Display Technology, Ltd. Related entities may recall under other names.
Next steps
- See all 5 Integrated Display Technology, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code DXN, Integrated Display Technology, Ltd.'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.