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

Radi Medical Systems AB — Predicate Candidate Screening

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

88 daysmedian FDA review time

188 days90th percentile

24clearances measured

K-number	Device	Applicant	Decided	Review days
K123984	QUANTIEN MEASUREMENT SYSTEM	Radi Medical Systems AB	2013-03-28	92
K092105	RADIANALYZER XPRESS	Radi Medical Systems AB	2009-10-09	87
K080813	PRESSUREWIRE CERTUS, CERTUS (300CM), AERIS, AERIS (300CM), R	Radi Medical Systems AB	2008-07-01	102
K080206	MODIFICATION TO FEMOSTOP FEMORAL COMPRESSION SYSTEM	Radi Medical Systems AB	2008-02-26	29
K062769	PRESSUREWIRE CERTUS, MODELS 12006 AND 12306	Radi Medical Systems AB	2006-12-04	80
K042628	MODIFICATION TO: RADIANALYZER, MODEL 12711	Radi Medical Systems AB	2005-01-19	114
K033291	TOPSEAL HEMOSTATIC DRESSING, MODEL 11150	Radi Medical Systems AB	2004-03-17	155
K031662	PRESSURE WIRE SENSOR, MODELS 12004/12304	Radi Medical Systems AB	2003-06-06	9
K024107	FEMOSTOP FEMORAL COMPRESSION SYSTEM	Radi Medical Systems AB	2002-12-24	11
K022188	RADIANALYZER, MODEL 12710	Radi Medical Systems AB	2002-10-03	90
K022187	PRESSURE WIRE SENSOR, MODELS 12003/12303, 12004/12304	Radi Medical Systems AB	2002-09-24	81
K013943	RADIANALYZER, MODEL 12710, RADIVIEW (PC-SOFTWARE ACCESSORY),	Radi Medical Systems AB	2001-12-18	19
K002067	RADIANALYZER, MODEL 12710	Radi Medical Systems AB	2001-01-11	188
K002962	PRESSURE WIRE SENSOR, MODEL 12003/12303	Radi Medical Systems AB	2000-10-04	12
K983471	FEMOSTOP COMPRESSION ARCH, FEMOSTOP PUMP, FEMOSTOP BILATERAL	Radi Medical Systems AB	1999-02-23	144
K983506	PRESSUREWIRE SENSOR, MODEL #12001	Radi Medical Systems AB	1999-02-03	119
K982182	FEMOSTOP II PLUS DISPOSABLE SET MODEL 11166, FEMOSTOP II PLU	Radi Medical Systems AB	1998-09-18	88
K972793	PRESSURE WIRE SENSOR .014, PRESSURE WIRE INTERFACE 10, PRESS	Radi Medical Systems AB	1998-04-24	270
K980898	FEMOSTOP II DISPOSABLE SET, FEMOSTOP II COMPRESSION ARCH, FE	Radi Medical Systems AB	1998-04-21	43
K962425	BONOPTY COAXIAL BONE BIOPSY SYSTEM WITH ECCENTRIC DRILL(10-1	Radi Medical Systems AB	1996-09-11	79
K954669	FEMOSTOP, FEMOSTOP PUMP	Radi Medical Systems AB	1995-10-27	17
K944259	FEMOSTOP II	Radi Medical Systems AB	1995-07-20	322
K915280	FEMOSTOP	Radi Medical Systems AB	1992-04-22	149
K903622	CT GUIDE (TM)	Radi Medical Systems AB	1990-10-29	81

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