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
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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
Regulatory Context
Review time vs. panel average
130d slower than avg
Panel avg: 140d · This submission: 270d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.