K092186 is an FDA 510(k) clearance for the VPAP TX. Classified as Ventilator, Continuous, Non-life-supporting (product code MNS), Class II - Special Controls.
Submitted by Resmed, Ltd. (San Diego, US). The FDA issued a Cleared decision on December 22, 2009 after a review of 154 days - an extended review cycle.
This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5895 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.
Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.
View all Resmed, Ltd. devices
NCT00850434
Completed
Interventional
Industry-sponsored
Improved Automatic CPAP Algorithm to Treat Obstructive Sleep Apnea (OSA)
Study of an Improved Automatic CPAP Algorithm for the Treatment of Obstructive Sleep Apnea
| Condition studied |
Obstructive Sleep Apnea (OSA) |
| Study design |
Crossover |
| Eligibility |
All sexes
· 18 Years+
|
| Principal investigator |
Klaus Schindhelm, PhD |
| Sponsor |
ResMed
(industry)
|
Started 2005-11-01
→
Primary completion 2008-09-01
→
Completed 2008-11-01
Primary outcome
Physiological sleep signals including EEG, Sp02, respiratory effort and nasal flow, will be recorded, analysed and reported in the form of a series of indices, which are the outcome variables of the study.
Study completed - no results published.
This trial concluded in 2008 but has not posted
results to ClinicalTrials.gov. Completed studies without public results are common
in industry-sponsored device trials; the data may be referenced in the
510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov