Kodon(Tianjin)Electronic&Electrical Apparatus Co.,: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Kodon(Tianjin)Electronic&Electrical Apparatus Co.,” (first 2003, latest 2007), across 1 product code in 1 review panel. Median 510(k) review time under this name: 174 days. 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 | 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 | 9 | 9 |
Review panels
- Cardiovascular (9)
Most recent Kodon(Tianjin)Electronic&Electrical Apparatus Co., 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K070828 | KD-595 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR | DXN | 2007-08-15 | 142 |
| K070826 | KD-795 WRIST MEASUREMENT ELECTRONIC BLOOD PRESSURE MONITOR | DXN | 2007-08-15 | 142 |
| K070395 | KD-525E FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR | DXN | 2007-06-07 | 118 |
| K052450 | KD-788 WRIST MEASUREMENT ELECTRONIC BLOOD PRESSURE MONITOR | DXN | 2006-02-28 | 174 |
| K052676 | KD-322 SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR | DXN | 2006-02-17 | 143 |
| K051847 | KD-768 WRIST MEASUREMENT ELECTRONIC BLOOD PRESSURE MONITOR | DXN | 2006-01-05 | 182 |
| K042418 | KD-575 MEMORY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR | DXN | 2005-03-21 | 199 |
| K030359 | KD-726 MEMORY WRIST AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR | DXN | 2003-11-06 | 276 |
| K030358 | KD-622 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR | DXN | 2003-10-31 | 270 |
Recalls
openFDA lists no recalls under a recalling firm named Kodon(Tianjin)Electronic&Electrical Apparatus Co.,.
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 Kodon(Tianjin)Electronic&Electrical Apparatus Co.,?
FDA lists 9 510(k) clearances under the applicant name “Kodon(Tianjin)Electronic&Electrical Apparatus Co.,” (first 2003, latest 2007), across 1 product code 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 Kodon(Tianjin)Electronic&Electrical Apparatus Co.,?
The median time from FDA receipt to decision across 510(k)s cleared under the name Kodon(Tianjin)Electronic&Electrical Apparatus Co., is 174 days.
Which FDA product codes appear under Kodon(Tianjin)Electronic&Electrical Apparatus Co.,?
The most frequent FDA product codes under this applicant name are DXN (System, Measurement, Blood-Pressure, Non-Invasive, 9).
Next steps
- See all 9 Kodon(Tianjin)Electronic&Electrical Apparatus Co., clearances with predicates and recalls
- Run predicate analysis for product code DXN, Kodon(Tianjin)Electronic&Electrical Apparatus Co.,'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.