Intai Technology Corp.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Intai Technology Corp.” (first 2006, latest 2022), across 4 product codes in 3 review panels. Median 510(k) review time under this name: 412 days. Since 2017 the median was 570 days, against 127 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 |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 249 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 1 | 570 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 2 | 542 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Intai Technology Corp. took a median 570 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 127 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | 2 | 2 |
| DZE | Implant, Endosseous, Root-Form | 1 | 1 |
| FXX | Mask, Surgical | 1 | 1 |
| OLO | Orthopedic Stereotaxic Instrument | 1 | 1 |
Review panels
- Orthopedic (3)
- Dental (1)
- General Hospital (1)
Most recent Intai Technology Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K210422 | INTAI Surgical Mask (non-sterile) | FXX | 2022-03-30 | 412 |
| K201229 | Intai Anatomic Locking Plate and Screw System | HRS | 2022-03-11 | 673 |
| K180523 | INTAI Surgery Navigation System | OLO | 2019-09-20 | 570 |
| K122804 | ROYAL-DENT EUREKA DENTAL IMPLANT SYSTEM | DZE | 2013-05-20 | 249 |
| K063020 | INTAI BONE PLATE AND BONE SCREW SYSTEM; INTAI DHS/DCS PLATE SYSTEM | HRS | 2006-12-14 | 73 |
Recalls
openFDA lists no recalls under a recalling firm named Intai Technology Corp..
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 Intai Technology Corp.?
FDA lists 5 510(k) clearances under the applicant name “Intai Technology Corp.” (first 2006, latest 2022), across 4 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 Intai Technology Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Intai Technology Corp. is 412 days. Since 2017: 570 days, versus 127 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Intai Technology Corp.?
The most frequent FDA product codes under this applicant name are HRS (Plate, Fixation, Bone, 2); DZE (Implant, Endosseous, Root-Form, 1); FXX (Mask, Surgical, 1).
Next steps
- See all 5 Intai Technology Corp. clearances with predicates and recalls
- Run predicate analysis for product code HRS, Intai Technology Corp.'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.