Cleared Traditional

K151874 - BiNAPS Nasal Airflow and Snore Transducer

Also marketed or referenced as:
ThermiSense Oral/Nasal Thermal AirFlow Sensor with Airflow Pressure Cannulas, Nasal and Oral/Nasal

K151874 is an FDA 510(k) clearance for BiNAPS Nasal Airflow and Snore Transducer, manufactured by Salter Labs. The device is a Class 2 Anesthesiology device with product code MNR cleared through the Traditional 510(k) pathway after a 281-day FDA review.

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

FDA 510(k) Submission Details - K151874

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
141d slower than avg
Panel avg: 140d · This submission: 281d
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.

Regulatory Peers - MNR Ventilatory Effort Recorder

All 62
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