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

Barcoview — Predicate Candidate Screening

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

32 daysmedian FDA review time

114 days90th percentile

17clearances measured

K-number	Device	Applicant	Decided	Review days
K062621	NIO 5MP-21 AND MDNG-5121 CB	Barcoview	2007-03-19	195
K062905	NIO FUSION 4MP; MDNC 4130	Barcoview	2006-12-29	93
K062131	NIO 5MP-M-21 (NIO 5MP MAMMO); MDNG-5121 BB	Barcoview	2006-11-17	114
K061927	CORONIS COLOR 3MP AND MDCC 3120-DL	Barcoview	2006-09-05	60
K061924	CORONIS 3MP AND MDCG 3120-CB	Barcoview	2006-09-05	60
K061928	CORONIS COLOR 2MP AND MDCC 2121	Barcoview	2006-09-05	60
K061926	CORONIS 2MP AND MDCG 2121 - CB	Barcoview	2006-08-18	42
K052958	COLOR NIO 2MP, E-2320 C	Barcoview	2005-11-16	26
K052352	COLOR CORONIS 2MP-21 AND MFCD 2321	Barcoview	2005-09-30	32
K052529	E-2320 PA S	Barcoview	2005-09-30	16
K052478	MFCD 1219, MFCD 1219 TS	Barcoview	2005-09-28	19
K052276	NIO 2MP-20 AND E-2620 S	Barcoview	2005-09-21	30
K052429	CORONIS 3MP-21 AND MFGD 3621	Barcoview	2005-09-15	9
K052403	CORONIS 2MP-21 AND MFGD 2621	Barcoview	2005-09-15	14
K051901	NIO 3MP-21	Barcoview	2005-08-17	35
K051902	NIO 2MP-21	Barcoview	2005-08-11	29
K051201	E1 MEDICAL FLAT PANEL DISPLAY SYSTEM AND MFGD 1218 MEDICAL F	Barcoview	2005-05-26	15

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