Cleared Traditional

K240285 - Huxley SANSA Home Sleep Apnea Test (1000-00) (FDA 510(k) Clearance)

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

K240285 · Huxley Medical · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2024
Decision
165d
Days
Class 2
Risk

K240285 is an FDA 510(k) clearance for the Huxley SANSA Home Sleep Apnea Test (1000-00). Classified as Ventilatory Effort Recorder (product code MNR), Class II - Special Controls.

Submitted by Huxley Medical (Atlanta, US). The FDA issued a Cleared decision on July 15, 2024 after a review of 165 days - an extended review cycle.

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. 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.

View all Huxley Medical devices

Submission Details

510(k) Number K240285 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 2024
Decision Date July 15, 2024
Days to Decision 165 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
26d slower than avg
Panel avg: 139d · This submission: 165d
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

Powers Regulatory Consulting
Grace Powers

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
NCT06070389 Completed Interventional Industry-sponsored

Polysomnography Validation of the Sansa Device

533
Patients (actual)
2
Sites
Diagnostic
Purpose
Open label
Masking
Condition studied Sleep-Disordered Breathing
Study design Single group
Eligibility All sexes · 18 Years+ · Healthy volunteers accepted
Principal investigator Cathy Goldstein
Sponsor Huxley Medical, Inc. (industry)
Started 2023-06-01 → Primary completion 2023-12-13
Primary outcome
Sensitivity and Specificity of the Sansa device to detect sleep disordered breathing compared to polysomnography
Study completed - no results published. This trial concluded in 2023 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.
View full study on ClinicalTrials.gov