Cleared Traditional

K151874 - BiNAPS Nasal Airflow and Snore Transducer (FDA 510(k) Clearance)

Also includes:
ThermiSense Oral/Nasal Thermal AirFlow Sensor with Airflow Pressure Cannulas, Nasal and Oral/Nasal

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

K151874 · Salter Labs · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2016
Decision
281d
Days
Class 2
Risk

K151874 is an FDA 510(k) clearance for the BiNAPS Nasal Airflow and Snore Transducer. Classified as Ventilatory Effort Recorder (product code MNR), Class II - Special Controls.

Submitted by Salter Labs (Carlsbad, US). The FDA issued a Cleared decision on April 15, 2016 after a review of 281 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 Salter Labs devices

Submission Details

510(k) Number K151874 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 2015
Decision Date April 15, 2016
Days to Decision 281 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
142d slower than avg
Panel avg: 139d · This submission: 281d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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