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

Radiometer Medical Aps — Predicate Candidate Screening

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

127 daysmedian FDA review time

338 days90th percentile

28clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K163462	AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLE	Radiometer Medical Aps	2017-09-21	286	0
K170882	ABL90 FLEX, ABL90 FLEX PLUS	Radiometer Medical Aps	2017-04-28	35	0
K160153	ABL90 FLEX PLUS	Radiometer Medical Aps	2016-11-04	287	1
K142898	ABL800 FLEX with AQURE connectivity	Radiometer Medical Aps	2015-06-17	254	3
K150226	Hematocrit and Metabolite QUALICHECK	Radiometer Medical Aps	2015-05-13	100	0
K132691	ABL90 FLEX	Radiometer Medical Aps	2014-11-13	442	0
K131988	ABL90 FLEX ANALYZER	Radiometer Medical Aps	2013-09-17	81	0
K130144	ABL90 FLEX	Radiometer Medical Aps	2013-07-31	190	3
K123748	ABL90 FLEX	Radiometer Medical Aps	2013-05-07	152	0
K130415	HIGH METABOLITE QUALICHECK	Radiometer Medical Aps	2013-03-26	35	0
K130236	RANGE + QUALICHECK LEVEL 1, RANGE + QUALICHECK LEVEL 2, RANG	Radiometer Medical Aps	2013-03-15	44	0
K120326	AQT90 FLEX CKMB TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LEVELS	Radiometer Medical Aps	2012-11-21	293	0
K122729	ABL90 FLEX	Radiometer Medical Aps	2012-11-16	71	0
K122642	ABL90 FLEX	Radiometer Medical Aps	2012-10-26	58	0
K120197	ABL90 FLEX	Radiometer Medical Aps	2012-03-19	56	2
K112161	AQT90 FLEX ANALYZER, AQT90 FLEX MYOGLOBIN TEST KIT, AQT90 FL	Radiometer Medical Aps	2012-01-20	177	0
K111897	ABL90	Radiometer Medical Aps	2011-07-19	14	2
K110416	ABL835 FLEX ANALYZER WITH PLEURAL PH	Radiometer Medical Aps	2011-03-24	38	2
K100777	ABL837 FLEX ANALYZER	Radiometer Medical Aps	2010-12-10	267	2
K092686	ABL90 FLEX SERIES	Radiometer Medical Aps	2010-08-06	338	5
K093154	TCM TOSCA MONITORING SYSTEM, TCM COMBIM MONITORING SYSTEM	Radiometer Medical Aps	2010-02-05	122	1
K051968	ABL8X7 FLEX	Radiometer Medical Aps	2006-10-16	453	3
K051928	AUTOCHECK6+	Radiometer Medical Aps	2005-10-12	86	0
K050869	MODIFICATION TO ABL800 FLEX	Radiometer Medical Aps	2005-08-11	127	1
K043218	ABL800 FLEX WITH FLEXQ MODULE, MODEL ABL8XX	Radiometer Medical Aps	2005-05-10	169	3
K043143	SAFEPICO	Radiometer Medical Aps	2005-04-22	158	1
K043003	TCM40 MONITORING SYSTEM	Radiometer Medical Aps	2005-03-01	120	2
K041874	ABL800 FLEX	Radiometer Medical Aps	2004-10-08	88	12

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