Contec Medical System Co., Ltd.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Contec Medical System Co., Ltd.” (first 2008, latest 2019), across 8 product codes in 3 review panels. Median 510(k) review time under this name: 164 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 | 1 | 253 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 1 | 286 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Contec Medical System Co., Ltd. took a median 286 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 195 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DQA | Oximeter | 3 | 3 |
| DPS | Electrocardiograph | 2 | 2 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 2 | 2 |
| CAW | Generator, Oxygen, Portable | 1 | 1 |
| KNG | Monitor, Ultrasonic, Fetal | 1 | 1 |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 1 | 1 |
| MLO | Electrocardiograph, Ambulatory, With Analysis Algorithm | 1 | 1 |
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | 1 | 1 |
Review panels
Most recent Contec Medical System Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K180837 | CONTEC Oxygen Concentrator | CAW | 2019-01-10 | 286 |
| K131900 | CONTEC ELECTROCARDIOGRAPH | DPS | 2014-03-05 | 253 |
| K101273 | DYNAMIC ECG SYSTEM MODEL TLC5000 | MLO | 2011-09-30 | 512 |
| K110156 | AMBULATORY BLLOD PRESSURE MONITOR, ELECTRONIC SPHYGMOMANOMETER, | DXN | 2011-07-27 | 189 |
| K101692 | PATIENT MONITOR | MHX | 2011-06-28 | 377 |
| K110774 | ELECTRONIC SPHYGMOMANOMETER | DXN | 2011-05-13 | 53 |
| K101127 | PATIENT MONITOR, MODEL PM50 | MWI | 2010-06-11 | 50 |
| K090936 | SINGLE-CHANNEL HANDHELD ELECTROCARDIOGRAPH, MODEL ECG80A | DPS | 2009-08-25 | 145 |
| K090671 | PULSE OXIMETER, MODELS CMS50E, CMS50F, CMS60C, CMS60D | DQA | 2009-06-11 | 90 |
| K082480 | CONTEC POCKET FETAL DOPPLER | KNG | 2009-02-25 | 181 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Contec Medical System Co., Ltd..
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 Systems 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 System Co., Ltd.?
FDA lists 12 510(k) clearances under the applicant name “Contec Medical System Co., Ltd.” (first 2008, latest 2019), across 8 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 Contec Medical System Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Contec Medical System Co., Ltd. is 164 days.
Which FDA product codes appear under Contec Medical System Co., Ltd.?
The most frequent FDA product codes under this applicant name are DQA (Oximeter, 3); DPS (Electrocardiograph, 2); DXN (System, Measurement, Blood-Pressure, Non-Invasive, 2).
Next steps
- See all 12 Contec Medical System Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code DQA, Contec Medical System 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.