Cleared Traditional

K250882 - SANSA HSAT (FDA 510(k) Clearance)

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

K250882 · Huxley Medical · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2025
Decision
219d
Days
Class 2
Risk

K250882 is an FDA 510(k) clearance for the SANSA HSAT. 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 October 29, 2025 after a review of 219 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 868.2375 - the FDA cardiovascular device oversight 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 Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Huxley Medical devices

Submission Details

510(k) Number K250882 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 2025
Decision Date October 29, 2025
Days to Decision 219 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
94d slower than avg
Panel avg: 125d · This submission: 219d
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 Cardiovascular 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
NCT06414447 Not yet recruiting Observational Industry-sponsored

Electrocardiogram (ECG) Validation Study

SANSA Electrocardiogram (ECG) Validation Study

15
Patients (est.)
Condition studied Arrythmia
Eligibility All sexes · 18 Years+ · Healthy volunteers accepted
Sponsor Huxley Medical, Inc. (industry)
Started 2024-05-01 → Primary completion 2024-06-01 → Completed 2024-07-01
Primary outcome
Comparison of the diagnostic Electrocardiogram (ECG) signal quality of the P, QRS and T wave deflections of the Sansa device to a reference standard Holter monitor
View full study on ClinicalTrials.gov

Regulatory Peers - MNR Ventilatory Effort Recorder

All 160
Devices cleared under the same product code (MNR) and FDA review panel - the closest regulatory comparables to K250882.
CASSIE
K252628 · Wesper, Inc. · Apr 2026
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K252383 · Compumedics Limited · Aug 2025
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K243220 · Onera B.V. · Jul 2025
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K242224 · Happy Health, Inc. · Jun 2025