Contec Medical Systems Co.,Ltd: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Contec Medical Systems Co.,Ltd” (first 2011, latest 2024), across 7 product codes in 5 review panels. Median 510(k) review time under this name: 234 days. Since 2017 the median was 228 days, against 140 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 | 0 | — |
| 2014 | 0 | — |
| 2015 | 1 | 335 |
| 2016 | 1 | 266 |
| 2017 | 2 | 150 |
| 2018 | 1 | 258 |
| 2019 | 0 | — |
| 2020 | 1 | 155 |
| 2021 | 1 | 219 |
| 2022 | 1 | 243 |
| 2023 | 0 | — |
| 2024 | 3 | 228 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Contec Medical Systems Co.,Ltd took a median 228 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 140 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DPS | Electrocardiograph | 3 | 3 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 2 | 2 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 2 | 2 |
| KNG | Monitor, Ultrasonic, Fetal | 2 | 2 |
| DQA | Oximeter | 1 | 1 |
| FLL | Continuous Measurement Thermometer | 1 | 1 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 1 | 1 |
Review panels
- Cardiovascular (5)
- Radiology (3)
- Obstetrics and Gynecology (2)
- Anesthesiology (1)
- General Hospital (1)
Most recent Contec Medical Systems Co.,Ltd 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K232893 | Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal Doppler (CONTEC 10F) | KNG | 2024-06-14 | 270 |
| K232895 | B-Ultrasound Diagnostic System | IYO | 2024-05-03 | 228 |
| K232908 | Color Doppler Ultrasound Diagnostic System (CMS1700B), Color Doppler Ultrasound Diagnostic System (CMS1700C) | IYN | 2024-05-02 | 226 |
| K220245 | Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL) | KNG | 2022-09-28 | 243 |
| K202757 | CONTEC08A Electronic Sphygmomanometer, CONTEC08C Electronic Sphygmomanometer, ABPM50 Automatic Blood Pressure Monitor | DXN | 2021-04-28 | 219 |
| K201980 | Infrared Thermometer | FLL | 2020-12-18 | 155 |
| K171360 | CONTEC Electrocardiograph | DPS | 2018-01-22 | 258 |
| K170856 | CMS600P2 B-Ultrasound Diagnostic System | IYO | 2017-11-17 | 240 |
| K170954 | Portable ECG Monitor | DPS | 2017-05-30 | 60 |
| K152863 | Portable ECG Monitor | DPS | 2016-06-22 | 266 |
2 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 1 initiated in the last five years. Most recent: 2025-04-10.
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Contec Medical System Co., Ltd. (12 510(k)s)
- Contec Medical Vision, Ltd. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Contec Medical Systems Co.,Ltd?
FDA lists 12 510(k) clearances under the applicant name “Contec Medical Systems Co.,Ltd” (first 2011, latest 2024), across 7 product codes in 5 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 Contec Medical Systems Co.,Ltd?
The median time from FDA receipt to decision across 510(k)s cleared under the name Contec Medical Systems Co.,Ltd is 234 days. Since 2017: 228 days, versus 140 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Contec Medical Systems Co.,Ltd?
The most frequent FDA product codes under this applicant name are DPS (Electrocardiograph, 3); DXN (System, Measurement, Blood-Pressure, Non-Invasive, 2); IYO (System, Imaging, Pulsed Echo, Ultrasonic, 2).
Next steps
- See all 12 Contec Medical Systems Co.,Ltd clearances with predicates and recalls
- Run predicate analysis for product code DPS, Contec Medical Systems Co.,Ltd'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.