Cleared Special

K220028 - NightOwl (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through the Special 510(k) pathway.

K220028 · Ectosense NV · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2022
Decision
50d
Days
Class 2
Risk

K220028 is an FDA 510(k) clearance for the NightOwl. Classified as Ventilatory Effort Recorder (product code MNR), Class II - Special Controls.

Submitted by Ectosense NV (Rotselaar, BE). The FDA issued a Cleared decision on February 24, 2022 after a review of 50 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2375 - the FDA anesthesiology and respiratory device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Ectosense NV devices

Submission Details

510(k) Number K220028 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 2022
Decision Date February 24, 2022
Days to Decision 50 days
Submission Type Special
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
89d faster than avg
Panel avg: 139d · This submission: 50d
Pathway characteristics
Modification to existing cleared device.

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 Anesthesiology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT04191668 Completed Interventional Industry-sponsored

A Validation Study of the NightOwl PAT-based Home Sleep Apnea Test

106
Patients (actual)
3
Sites
Diagnostic
Purpose
Open label
Masking
Condition studied Sleep Apnea
Study design Single group
Eligibility All sexes · 13 Years+ · Healthy volunteers accepted
Principal investigator Frederik Massie, MSc
Sponsor Ectosense NV (industry)
Started 2019-12-02 → Primary completion 2020-02-01
Primary outcome
Pearson Correlation Between the AHI
View full study on ClinicalTrials.gov