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

Rossmax International , Ltd. — Predicate Candidate Screening

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

78 daysmedian FDA review time

90 days90th percentile

16clearances measured

K-number	Device	Applicant	Decided	Review days
K060342	ROSSMAX AUTOMATIC BLOOD PRESSURE MONITOR MODEL MO701K	Rossmax International , Ltd.	2006-04-04	53
K052727	ROSSMAX NON-INVASIVE BLOOD PRESSURE MONITORS, MODELS S380, K	Rossmax International , Ltd.	2005-12-16	78
K021225	ROSSMAX AUTOMATIC BLOOD PRESSURE MONITOR, MODEL CARDIOCARE 1	Rossmax International , Ltd.	2002-05-22	34
K013539	ROSSMAX MEDIPRO, MODELS 100F, 200F, AND 300F BLOOD PRESSURE	Rossmax International , Ltd.	2002-01-17	85
K013583	ROSSMAX MEDIPRO MODEL 10 AND 60, MEDICARE MODEL 10 AND 60 BL	Rossmax International , Ltd.	2002-01-17	79
K011539	ROSSMAX MEDIPRO MODEL 100, MODEL 200, AND MODEL 300 BLOOD PR	Rossmax International , Ltd.	2001-07-20	63
K011352	ROSSMAX SMARTINFLATE CARDIOPRO, MODEL 1000I AND MODEL 3000I	Rossmax International , Ltd.	2001-07-20	78
K011523	ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL B	Rossmax International , Ltd.	2001-06-14	28
K993460	ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z	Rossmax International , Ltd.	2000-01-11	90
K993426	ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z	Rossmax International , Ltd.	2000-01-07	87
K993429	ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z	Rossmax International , Ltd.	2000-01-07	87
K993542	ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL V	Rossmax International , Ltd.	1999-12-29	71
K993432	ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z	Rossmax International , Ltd.	1999-12-20	69
K992387	ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL R	Rossmax International , Ltd.	1999-08-03	15
K992388	ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL R	Rossmax International , Ltd.	1999-08-03	15
K964153	ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL R	Rossmax International , Ltd.	1998-06-11	603

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