Cleared Traditional

K251480 - PV01 PVDF Effort Sensor (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K251480 · Neurotronics, LLC · Anesthesiology device
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Aug 2025
Decision
108d
Days
Class 2
Risk

K251480 is an FDA 510(k) clearance for the PV01 PVDF Effort Sensor. Classified as Respiratory Effort Belt For Polysomnography (product code SFK), Class II - Special Controls.

Submitted by Neurotronics, LLC (Alachua, US). The FDA issued a Cleared decision on August 29, 2025 after a review of 108 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 882.1400 - 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.

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Submission Details

510(k) Number K251480 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 2025
Decision Date August 29, 2025
Days to Decision 108 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
31d faster than avg
Panel avg: 139d · This submission: 108d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code SFK Respiratory Effort Belt For Polysomnography
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1400
Definition To Assess Respiratory/breathing Effort By Measuring The Movement Of Chest And Abdominal Walls. The Belts Function As Accessories To Sleep/polysomnography (psg) And Home Sleep Apnea Test (hsat) Systems.
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.