Cleared Traditional

NightOwl (K191031) - FDA 510(k) Clearance

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

K191031 · Ectosense NV · Anesthesiology device
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Mar 2020
Decision
323d
Days
Class 2
Risk

K191031 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 March 6, 2020 after a review of 323 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2375 - 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. Elevated predicate reliance profile. 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 Ectosense NV devices

Submission Details

510(k) Number K191031 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 2019
Decision Date March 06, 2020
Days to Decision 323 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
183d slower than avg
Panel avg: 140d · This submission: 323d
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 Anesthesiology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT03774199 Unknown Interventional Industry-sponsored

NightOwl Pulse Oximeter Calibration Study

30
Patients (est.)
1
Site
Basic_science
Purpose
Open label
Masking
Condition studied Pulse Oximeter Calibration
Study design Single group
Eligibility All sexes · 13 Years+ · Healthy volunteers accepted
Sponsor Ectosense NV (industry)
Started 2018-12-14 → Primary completion 2019-12-14 → Completed 2020-04-14
Primary outcome
A_rms determination
View full study on ClinicalTrials.gov

Regulatory Peers - MNR Ventilatory Effort Recorder

All 53
Devices cleared under the same product code (MNR) and FDA review panel - the closest regulatory comparables to K191031.
Maxxi Flow Sensor
K201495 · Neurovirtual USA, Inc. · Dec 2020
MATRx plus
K200695 · Zephyr Sleep Technologies · Aug 2020
Rubicon SA System
K200654 · Dymedix Diagnostics, Inc. · Jul 2020
Maxxi Snore Sensor
K191095 · Neurovirtual USA, Inc. · Jan 2020
MATRx Plus
K191925 · Zephyr Sleep Technologies · Oct 2019
SomnaPatch
K183625 · Respironics, Inc. · Oct 2019