Aerocrine AB: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Aerocrine AB” (first 2008, latest 2015), plus 1 De Novo decision, across 1 product code in 1 review panel. Median 510(k) review time under this name: 141 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 27 |
| 2013 | 0 | — |
| 2014 | 1 | 321 |
| 2015 | 1 | 24 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MXA | System, Test, Breath Nitric Oxide | 6 | 5 |
Review panels
Most recent Aerocrine AB 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K150233 | NIOX VERO Airway Inflammation Monitor | MXA | 2015-02-26 | 24 |
| K133898 | NIOX VERO AIRWAY INFLAMMATION MONITOR | MXA | 2014-11-06 | 321 |
| K123683 | NIOX PANEL FOR USE WITH THE NIOX MINO AIRWAY INFLAMMATION MONITOR | MXA | 2012-12-27 | 27 |
| K101034 | NIOX MINO MODEL 09-1000 | MXA | 2010-09-02 | 141 |
| K072816 | NIOX MINO | MXA | 2008-03-03 | 153 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN030001 | De Novo | System, Test, Breath Nitric Oxide | 2003-04-30 |
Recalls
openFDA lists no recalls under a recalling firm named Aerocrine AB.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Aerocrine AB is the lead sponsor of 5 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT01729247: Study to Evaluate the Impact of FeNO Assessments on Asthma Management Decisions in Subject 7 to 60 Years of Age (Completed, started 2012-10)
- NCT01648920: A Study to Explore the Utility of Fractional Exhaled Nitric Oxide (FeNO) Compared With Methacholine Challenge (MCC) Testing in the Assessment of Patients With Suspected But Undiagnosed Asthma (Completed, started 2012-06)
- NCT01634620: Use of FeNO to Identify Eosinophilic Inflammation in Patients Age 40 Years and Above With Chronic Obstructive Airways Disease (Completed, started 2012-06)
- NCT01518322: Impact of FeNO Measured With the NIOX MINO® Device in Identifying Asthma Among Patients With Prolonged Respiratory Symptoms (Completed, started 2011-11)
- NCT00388570: Study of Monitoring Exhaled NO in Symptomatic Asthmatic Adults and Children During Anti-inflammatory Treatment (Completed, started 2006-10)
Frequently asked questions
How many FDA 510(k) clearances are listed under Aerocrine AB?
FDA lists 5 510(k) clearances under the applicant name “Aerocrine AB” (first 2008, latest 2015), plus 1 De Novo decision, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Aerocrine AB?
The median time from FDA receipt to decision across 510(k)s cleared under the name Aerocrine AB is 141 days.
Which FDA product codes appear under Aerocrine AB?
The most frequent FDA product codes under this applicant name are MXA (System, Test, Breath Nitric Oxide, 6).
Next steps
- See all 5 Aerocrine AB clearances with predicates and recalls
- Run predicate analysis for product code MXA, Aerocrine AB's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.