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

Cepheid — Predicate Candidate Screening

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

88 daysmedian FDA review time

210 days90th percentile

62clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K261362	Xpert Hemorrhagic Fever	Cepheid	2026-08-07	102	0
K261867	Xpert Carba-R	Cepheid®	2026-07-02	28	0
K253653	Xpert Hemorrhagic Fever	Cepheid	2026-02-20	92	0
K251721	Xpert GI Panel	Cepheid	2026-01-16	226	0
K250996	Xpert Xpress CoV-2/Flu/RSV plus	Cepheid®	2025-05-01	30	0
K250995	Xpert Xpress CoV-2/Flu/RSV plus	Cepheid®	2025-05-01	30	0
K243730	Xpert C. difficile/Epi	Cepheid®	2025-02-28	87	0
K250218	Xpert® FII & FV	Cepheid	2025-02-21	28	0
K242109	Xpert® Xpress CoV-2 plus (XPRS-COV2-10)	Cepheid®	2025-01-15	180	0
K242071	Xpert Xpress CoV-2/Flu/RSV plus	Cepheid	2025-01-10	178	0
K243625	Xpert MRSA/SA SSTI	Cepheid®	2024-12-18	23	0
K243405	Xpert vanA	Cepheid®	2024-11-21	20	0
K243070	Xpert® SA Nasal Complete	Cepheid®	2024-10-25	28	1
DEN240016	Xpert HCV; GeneXpert Xpress System	Cepheid	2024-06-27	72	0
K231381	Xpert Xpress MVP; GeneXpert Xpress System	Cepheid	2023-10-19	160	0
K230440	Xpert® Xpress CoV-2 plus	Cepheid®	2023-10-13	234	0
K222638	Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity	Cepheid	2023-09-27	391	0
K231481	Xpert Xpress CoV-2/Flu/RSV plus	Cepheid®	2023-08-17	86	0
K223046	Xpert® FII & FV	Cepheid®	2023-02-15	139	0
K221160	Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity Sy	Cepheid	2022-06-07	47	0
K203429	Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity Sys	Cepheid	2022-05-09	535	0
K212213	Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity Sy	Cepheid	2022-02-09	209	0
K190076	Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity	Cepheid	2019-09-27	254	1
K190441	Xpert CT/NG, GeneXpert Dx System, GeneXpert Infinity-48s and	Cepheid	2019-05-23	87	0
K190771	Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert	Cepheid	2019-04-25	30	0
K181289	Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit	Cepheid	2018-08-15	91	0
K180218	Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection	Cepheid	2018-07-24	180	0
K173398	Xpert Xpress Strep A	Cepheid	2018-04-26	177	0
K173840	Xpert CT/NG	Cepheid	2018-03-16	88	0
K173263	Xpert Carba-R	Cepheid	2018-01-09	90	0
K171552	Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit	Cepheid	2017-12-19	207	0
K172126	Xpert Xpress Strep A	Cepheid	2017-09-25	73	2
K162456	Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit	Cepheid	2017-02-13	164	0
K162331	Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection	Cepheid	2017-02-09	174	0
K162444	Xpert MRSA NxG	Cepheid	2016-11-23	84	0
K161619	Xpert TV, Xpert Urine Specimen Collection Kit, GeneXpert Dx	Cepheid	2016-08-29	77	0
K160901	Xpert Carba-R	Cepheid	2016-06-29	89	0
K152614	Xpert Carba-R	Cepheid	2016-03-07	175	0
K151226	Xpert Flu+RSV Xpress, Xpert Nasopharyngeal Sample Collection	Cepheid	2015-12-03	210	0
K151565	Xpert® TV Assay on the Cepheid GeneXpert Instrument Systems	Cepheid	2015-10-16	128	0
K143302	Xpert MTB/RIF Assay, GeneXpert Dx, GeneXpert Infinity-48, Ge	Cepheid	2015-02-12	87	1
K142501	Xpert Norovirus, GeneXpert Dx Systems (GX-I, GX-11, GX-IV, G	Cepheid	2014-11-26	82	0
K142045	XPERT FLU/RSV XC ASSAY	Cepheid	2014-11-22	117	0
DEN130032	XPERT MTB/RIF ASSAY	Cepheid	2013-07-25	44	0
K130894	XPERT MRSA/SA BLOOD CULTURE ASSAY; GENEXPERT DX SYSTEMS (GX-	Cepheid	2013-06-20	80	0
K121710	XPERT CT/NG	Cepheid	2012-12-27	199	2
K123191	XPERT FLU	Cepheid	2012-12-21	71	0
K121539	XPERT GBS LB GENEXPERT DX SYSTEMS (GX-I, GX-IV) GENEXPERT DX	Cepheid	2012-11-02	162	0
K120911	XPERT FLU GENEXPERT DX SYSTEMS (GX-I, GX-IV)	Cepheid	2012-05-18	53	0
K103766	XPERT FLU, GENEXPERT DX SYSTEMS, GENEXPERT INFINITY SYSTEM,	Cepheid	2011-04-21	119	1

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