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

HORIBA ABX SAS · Predicate Candidate Screening

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

229 daysmedian FDA review time

431 days90th percentile

17clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K232946	Yumizen H2500	HORIBA ABX SAS	2024-05-21	244	0
K193649	Yumizen C1200 Creatinine PAP	HORIBA ABX SAS	2021-05-10	497	0
K193525	Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin	HORIBA ABX SAS	2020-06-26	190	0
K192028	Yumizen C1200 CRP	HORIBA ABX SAS	2020-06-25	335	0
K191562	Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C	HORIBA ABX SAS	2020-03-06	267	0
K191993	Yumizen C1200 CRP	HORIBA ABX SAS	2019-10-03	70	0
K191245	Yumizen C1200 ALP, Yumizen C1200 Albumin	HORIBA ABX SAS	2019-08-30	113	0
K191396	Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe	HORIBA ABX SAS	2019-07-26	63	0
K170353	ABX MICROS ES 60 OT and ABX MICROS ES 60 CT	HORIBA ABX SAS	2017-11-01	271	0
K151133	PENTRA XLR	HORIBA ABX SAS	2015-12-09	225	0
K141161	ABX MICROS ES 60 CT; (OPEN TUBE MODEL), (CLOSE TUBE MODEL)	HORIBA ABX SAS	2014-12-20	229	0
K133676	ABX PENTRA MICRO ALB CONTROL L/H	HORIBA ABX SAS	2014-07-11	224	0
K123171	ABX PENTRA CALCIUM AS CP, ABX PENTRA URINE CONTROL L/H, ABX	HORIBA ABX SAS	2013-07-03	267	0
K110530	ABX PENTRA CREATININE 120 CP; ABX PENTRA MULTICAL; ABX PENTR	HORIBA ABX SAS	2012-04-30	431	3
K103788	PENTRA C200, ISE MODULE AND ABX PENTRA GLUCOSE HK CP REAGENT	HORIBA ABX SAS	2011-11-08	316	1
K110137	ABX PENTRA ENZYMATIC CREATININE CP, ABX PENTRA MULTICAL, ABX	HORIBA ABX SAS	2011-08-10	204	2
K092570	ABX PENTRA TPU CAL, MODEL A11A01898	HORIBA ABX SAS	2009-10-16	56	0

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