Atlas FDA

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

MXA — Predicate Candidate Screening

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

141 daysmedian FDA review time
364 days90th percentile
15clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K251674Fenom Flo™ FeNO Monitoring SystemMgc Diagnostics Corporation2025-11-261800
K243926Vivatmo pro-SBosch Healthcare Solutions GmbH2025-09-112650
K233775Vivatmo proBosch Healthcare Solutions GmbH2024-02-22900
K213611Fenom ProCaire Diagnostics, Inc.2023-06-075690
K203695NObreath®Bedfont Scientific, Ltd.2021-12-173640
K182874Fenom Pro Nitric Oxide TestSpirosure, Inc.2019-02-131240
K170983NIOX VEROCircassia AB2017-11-222330
K150233NIOX VERO Airway Inflammation MonitorAerocrine AB2015-02-26240
K133898NIOX VERO AIRWAY INFLAMMATION MONITORAerocrine AB2014-11-063210
K123683NIOX PANEL FOR USE WITH THE NIOX MINO AIRWAY INFLAMMATION MOAerocrine AB2012-12-27270
K101034NIOX MINO MODEL 09-1000Aerocrine AB2010-09-021410
K083617APIERON INSIGHT ENO SYSTEMApieron, Inc.2009-01-27500
K073265APIERON INSIGHT EXHALED NITRIC OXIDE (ENO) SYSTEMApieron, Inc.2008-03-141150
K072816NIOX MINOAerocrine AB2008-03-031530
DEN030001NIOX ARTICLE NO: 02-1000Aerocrine AB2003-04-30430

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