Cleared Traditional

Onera Sleep Test System (Onera STS) (K210593) - FDA 510(k) Clearance

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

K210593 · Onera B.V. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2022
Decision
401d
Days
Class 2
Risk

K210593 is an FDA 510(k) clearance for the Onera Sleep Test System (Onera STS). Classified as Ventilatory Effort Recorder (product code MNR), Class II - Special Controls.

Submitted by Onera B.V. (Eindhoven, NL). The FDA issued a Cleared decision on April 6, 2022 after a review of 401 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 868.2375 - the FDA neurology 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

View all Onera B.V. devices

Submission Details

510(k) Number K210593 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2021
Decision Date April 06, 2022
Days to Decision 401 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
253d slower than avg
Panel avg: 148d · This submission: 401d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MNR Ventilatory Effort Recorder
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2375
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 Neurology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT04446247 Completed Observational Industry-sponsored

Accuracy of Owlet Smart Sock Sensor 3rd Generation With Profound Hypoxia

14
Patients (actual)
1
Site
Condition studied Hypoxia
Eligibility All sexes · 18 Years+ · Healthy volunteers accepted
Principal investigator Philip Bickler, MD
Sponsor Owlet Baby Care, Inc. (industry)
Started 2020-03-12 → Primary completion 2020-03-13
Primary outcome
SpO2 Accuracy (Arms) of ≤3 Between 70 and 100%
View full study on ClinicalTrials.gov