Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Jawon Medical Co., Ltd. · Predicate Candidate Screening

13 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

62 daysmedian FDA review time
406 days90th percentile
13clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K140762AUTOMATIC BLOOD PRESSURE MONITORJawon Medical Co., Ltd.2015-07-024620
K140045BODY COMPOSITION ANALYZERJawon Medical Co., Ltd.2015-02-184060
K092432AUTOMOATIC BLOOD PRESSURE MONITOR, MODELS: EASY X 800 AND 90Jawon Medical Co., Ltd.2009-10-09630
K092431BODY COMPOSITION ANALYZER, MODEL: IOI 353Jawon Medical Co., Ltd.2009-10-08620
K072325BODY COMPOSITION ANALYZER, EASYBODY 202, 203, 205Jawon Medical Co., Ltd.2007-11-301020
K071884BODY COMPOSITION ANALYZER, MODELS: X-SCAN PLUS II, GAIA 359 Jawon Medical Co., Ltd.2007-08-09310
K062462NON-INVASIVE BLOOD PRESSURE MONITOR, MODELS FT-500R/L AND FTJawon Medical Co., Ltd.2006-09-29360
K053556BODY COMPOSITION ANALYZER, MODELS ZEUS 9.9 AND VENUS 5.5Jawon Medical Co., Ltd.2006-08-312540
K013876INFRARED EAR THERMOMETER, MODEL DX-707Jawon Medical Co., Ltd.2002-03-041010
K002722DIGITAL BLOOD PRESSURE MONITOR, MODELS HD-503 AND HD-505Jawon Medical Co., Ltd.2000-09-11110
K000675MANUAL DIGITAL BLOOD PRESSURE MONITOR, MODEL HD-502Jawon Medical Co., Ltd.2000-03-14150
K991688WRIST TYPE DIGITAL BLOOD PRESSURE MONITOR, MODEL HD-303SJawon Medical Co., Ltd.1999-06-01150
K983855FUZZY TYPE DIGITAL BLOOD PRESSURE MONITOR, MODEL #'S HD-1000Jawon Medical Co., Ltd.1998-11-17150

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda