Cleared Traditional

K253148 - RX-1 Sleep

K253148 is an FDA 510(k) clearance for RX-1 Sleep, manufactured by Vivaquant, Inc. Dba Rhythm Express. The device is a Class 2 Anesthesiology device with product code MNR cleared through the Traditional 510(k) pathway after a 270-day FDA review.

K253148 · Vivaquant, Inc. Dba Rhythm Express · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2026
Decision
270d
Days
Class 2
Risk

K253148 is an FDA 510(k) clearance for the RX-1 Sleep. Classified as Ventilatory Effort Recorder (product code MNR), Class II - Special Controls.

Submitted by Vivaquant, Inc. Dba Rhythm Express (Arden Hills, US). The FDA issued a Cleared decision on June 22, 2026 after a review of 270 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 Vivaquant, Inc. Dba Rhythm Express devices

FDA 510(k) Submission Details - K253148

510(k) Number K253148 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2025
Decision Date June 22, 2026
Days to Decision 270 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
130d slower than avg
Panel avg: 140d · This submission: 270d
Pathway characteristics
Predicate-based equivalence.

MNR Device Classification - Class 2, Special Controls

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

DuVal & Associates, P.A.
Kathy Herzog

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
NCT06907888 Completed Observational Industry-sponsored

Rhythm Express Wearable System vs. Simultaneous Polysomnography for the Diagnosis of Obstructive Sleep Apnea in Adults With Suspected or Observed Atrial Fibrillation

A Confirmatory Study to Evaluate the Rhythm Express Wearable System vs. Simultaneous Polysomnography (PSG) for the Diagnosis of Obstructive Sleep Apnea in an Adult Population With Observed or Suspected Atrial Fibrillation, and Are Indicated for Ambulatory Cardiac Monitoring

30
Patients (actual)
4
Sites
Condition studied Obstructive Sleep Apnea (OSA); Atrial Fibrillation (Paroxysmal); Palpitations
Eligibility All sexes · 21 Years+
Principal investigator Brian Brockway
Sponsor VivaQuant (industry)
Started 2024-11-18 → Primary completion 2025-06-16 → Completed 2025-06-25
Primary outcome
Sensitivity and Specificity (AHI>5)
Secondary outcome
Sensitivity and Specificity (AHI>15)
Study completed - no results published. This trial concluded in 2025 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

Regulatory Peers - MNR Ventilatory Effort Recorder

All 156
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