Cleared Traditional

DROWZLE (K173974) - FDA 510(k) Clearance

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

K173974 · Resonea, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2019
Decision
562d
Days
Class 2
Risk

K173974 is an FDA 510(k) clearance for the DROWZLE. Classified as Ventilatory Effort Recorder (product code MNR), Class II - Special Controls.

Submitted by Resonea, Inc. (Scottsdale, US). The FDA issued a Cleared decision on July 14, 2019 after a review of 562 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: 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 Anesthesiology submissions.

View all Resonea, Inc. devices

Submission Details

510(k) Number K173974 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 2017
Decision Date July 14, 2019
Days to Decision 562 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
423d slower than avg
Panel avg: 139d · This submission: 562d
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.

Regulatory Consultant

Graematter, Inc.
Melissa Walker

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Clinical Evidence

ClinicalTrials.gov
NCT03288376 Completed Observational Industry-sponsored

SNORE (Smartphone Analyses of Nocturnal Obstruction by Respiratory Evaluation) SOUNDS

272
Patients (actual)
3
Sites
Condition studied Sleep Apnea, Obstructive; Chronic Obstructive Pulmonary Disease
Eligibility All sexes · 18 Years+ · Healthy volunteers accepted
Principal investigator Ruchir Sehra, MD
Sponsor Incyphae, Inc. (industry)
Started 2015-02-13 → Primary completion 2017-01-31
Primary outcome
Agreement between algorithm with PSG reference standard for detection of OSA at an AHI cut-off of 15
Secondary outcome
Comparison between algorithm and PSG assignment of OSA severity based on AHI [0-4 normal/minimal OSA, 5-14 mild, 15-30 moderate, >30 severe].
Study completed - no results published. This trial concluded in 2017 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