Bontech, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Bontech, Inc.” (first 2016, latest 2025), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 37 days. Since 2017 the median was 30 days, against 48 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 |
|---|---|---|
| 2016 | 2 | 85 |
| 2017 | 1 | 30 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 28 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 1 | 269 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Bontech, Inc. took a median 30 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 48 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | 4 | 4 |
| IZL | System, X-Ray, Mobile | 1 | 1 |
Review panels
- Radiology (5)
Most recent Bontech, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K243864 | BONX805 | IZL | 2025-09-12 | 269 |
| K200787 | BSD3543W | MQB | 2020-04-23 | 28 |
| K171485 | BSD4343R Digital Flat Panel X-ray Detector | MQB | 2017-06-21 | 30 |
| K162487 | BSD3543 Digital Flat Panel X-ray Detector | MQB | 2016-10-14 | 37 |
| K160204 | BSD4343 Digital Flat Panel X-ray Detector | MQB | 2016-06-09 | 133 |
Recalls
openFDA lists no recalls under a recalling firm named Bontech, Inc..
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 Bontech, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Bontech, Inc.” (first 2016, latest 2025), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Bontech, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Bontech, Inc. is 37 days. Since 2017: 30 days, versus 48 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Bontech, Inc.?
The most frequent FDA product codes under this applicant name are MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager), 4); IZL (System, X-Ray, Mobile, 1).
Next steps
- See all 5 Bontech, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MQB, Bontech, Inc.'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.