Cleared Traditional

K212555 - Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftN, Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftNHC (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence.

K212555 · Covidien, LLC · Anesthesiology device

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May 2022

Decision

266d

Days

Class 2

Risk

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.

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Submission Details

510(k) Number	K212555 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 13, 2021
Decision Date	May 06, 2022
Days to Decision	266 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

127d slower than avg

Panel avg: 139d · This submission: 266d

Pathway characteristics

Predicate-based equivalence.

Device Classification

Product Code	DQA Oximeter
Device Class	Class 2 - Special Controls
CFR Regulation	21 CFR 870.2700

What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Anesthesiology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov

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

Patients (actual)

Site

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