Jawon Medical Co., Ltd.: FDA clearances and approvals
Jawon Medical Co., Ltd. has 13 FDA 510(k) clearances (first 1998, latest 2015), across 3 product codes in 3 review panels. Median 510(k) review time: 62 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 2 | 434 |
| 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 | 7 | 7 |
| MNW | Analyzer, Body Composition | 5 | 5 |
| FLL | Continuous Measurement Thermometer | 1 | 1 |
Review panels
Most recent Jawon Medical Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K140762 | AUTOMATIC BLOOD PRESSURE MONITOR | DXN | 2015-07-02 | 462 |
| K140045 | BODY COMPOSITION ANALYZER | MNW | 2015-02-18 | 406 |
| K092432 | AUTOMOATIC BLOOD PRESSURE MONITOR, MODELS: EASY X 800 AND 900 (R/L) | DXN | 2009-10-09 | 63 |
| K092431 | BODY COMPOSITION ANALYZER, MODEL: IOI 353 | MNW | 2009-10-08 | 62 |
| K072325 | BODY COMPOSITION ANALYZER, EASYBODY 202, 203, 205 | MNW | 2007-11-30 | 102 |
| K071884 | BODY COMPOSITION ANALYZER, MODELS: X-SCAN PLUS II, GAIA 359 PLUS, PLUSAVIS 333, XBIA 500, XBIA 900 | MNW | 2007-08-09 | 31 |
| K062462 | NON-INVASIVE BLOOD PRESSURE MONITOR, MODELS FT-500R/L AND FT-700R/L | DXN | 2006-09-29 | 36 |
| K053556 | BODY COMPOSITION ANALYZER, MODELS ZEUS 9.9 AND VENUS 5.5 | MNW | 2006-08-31 | 254 |
| K013876 | INFRARED EAR THERMOMETER, MODEL DX-707 | FLL | 2002-03-04 | 101 |
| K002722 | DIGITAL BLOOD PRESSURE MONITOR, MODELS HD-503 AND HD-505 | DXN | 2000-09-11 | 11 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Jawon Medical Co., Ltd..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Jawon Medical Co., Ltd. have?
Jawon Medical Co., Ltd. has 13 FDA 510(k) clearances (first 1998, latest 2015), across 3 product codes in 3 review panels.
How long does FDA take to clear Jawon Medical Co., Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Jawon Medical Co., Ltd.'s cleared 510(k)s is 62 days.
What devices does Jawon Medical Co., Ltd. make?
Its most frequent FDA product codes are DXN (System, Measurement, Blood-Pressure, Non-Invasive, 7); MNW (Analyzer, Body Composition, 5); FLL (Continuous Measurement Thermometer, 1).
Has Jawon Medical Co., Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Jawon Medical Co., Ltd. Related entities may recall under other names.
Next steps
- See all 13 Jawon Medical Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code DXN, Jawon Medical Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.