K212555 is an FDA 510(k) clearance for the Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftN, Nellcor OxySoft Neonata.... Classified as Oximeter (product code DQA), Class II - Special Controls.
Submitted by Covidien, LLC (Boulder, US). The FDA issued a Cleared decision on May 6, 2022 after a review of 266 days - an extended review cycle.
This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 870.2700 - 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 Covidien, LLC devices
NCT04559763
Completed
Observational
Industry-sponsored
SpO2 Accuracy Validation of the OxySoft Sensor Via Reference CO-Oximetry Motion Study
SpO2 Accuracy Validation of the OxySoft Sensor Via Reference CO-Oximetry, During Motion and Non-Motion Conditions in Healthy, Well-Perfused Subjects
| Condition studied |
Hypoxia; Desaturation of Blood |
| Eligibility |
All sexes
· 18 Years+
· Healthy volunteers accepted
|
| Principal investigator |
Arthur Cabrera, MD |
| Sponsor |
Medtronic - MITG
(industry)
|
Started 2020-08-18
→
Primary completion 2020-08-21
Primary outcome
To investigate performance of the OxySoft device by measuring oxygen saturation accuracy during motion and non-motion conditions
Study completed - no results published.
This trial concluded in 2020 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510(k) Summary PDF or remain unpublished.
Individual participant data will not be shared.
View full study on ClinicalTrials.gov