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

Aerocrine AB · Predicate Candidate Screening

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

141 daysmedian FDA review time

321 days90th percentile

6clearances measured

K-number	Device	Applicant	Decided	Review days
K150233	NIOX VERO Airway Inflammation Monitor	Aerocrine AB	2015-02-26	24
K133898	NIOX VERO AIRWAY INFLAMMATION MONITOR	Aerocrine AB	2014-11-06	321
K123683	NIOX PANEL FOR USE WITH THE NIOX MINO AIRWAY INFLAMMATION MO	Aerocrine AB	2012-12-27	27
K101034	NIOX MINO MODEL 09-1000	Aerocrine AB	2010-09-02	141
K072816	NIOX MINO	Aerocrine AB	2008-03-03	153
DEN030001	NIOX ARTICLE NO: 02-1000	Aerocrine AB	2003-04-30	43

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