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

NXO — Predicate Candidate Screening

15 FDA 510(k) clearances under this product code; the 50 most recent screened below.

112 daysmedian FDA review time

287 days90th percentile

15clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K232057	BÜHLMANN fCAL® turbo and CALEX® Cap	Bühlmann Laboratories AG	2024-02-06	210	0
K220763	ALPCO Calprotectin Immunoturbidimetric Assay	ALPCO	2023-04-13	393	0
K213858	LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus	DiaSorin, Inc.	2022-07-26	228	1
K191807	ALPCO Calprotectin Chemiluminescence ELISA, ALPCO Easy Stool	ALPCO	2019-10-25	112	0
K191718	Buhlmann fCAL turbo and CALEX Cap	Buhlmann Laboratories AG	2019-09-24	90	0
K191589	Calprest, EasyCal	Eurospital S.P.A.	2019-07-10	26	0
K191592	CalprestNG, EasyCal	Eurospital S.P.A.	2019-07-10	26	0
K190784	BUHLMANN fCAL turbo	Buhlmann Laboratories AG	2019-06-25	90	0
K182698	LIAISON Calprotectin, LIAISON Calprotectin Control Set, LIAI	DiaSorin, Inc.	2018-12-26	90	0
K180971	QUANTA Flash Calprotectin and Fecal Extraction Device	Inova Diagnostics, Inc.	2018-10-16	186	0
K181012	BUHLMANN fCAL ELISA	Buhlmann Laboratories AG	2018-06-04	48	0
K170993	QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotecti	Inova Diagnostics, Inc.	2017-12-22	263	0
K160447	Calprest NG	Eurospital S.P.A.	2016-11-10	267	0
K130945	CALPREST	Eurospital S.P.A.	2014-01-16	287	0
DEN060001	PHICAL TEST	Genova Diagnostics	2006-04-26	34	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