Cleared Traditional

K051313 - BI-NAPS NASAL AIRFLOW AND SNORE TRANSDUCER

K051313 is an FDA 510(k) clearance for BI-NAPS 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 119-day FDA review.

K051313 · Salter Labs · Anesthesiology device
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Sep 2005
Decision
119d
Days
Class 2
Risk

K051313 is an FDA 510(k) clearance for the BI-NAPS NASAL AIRFLOW AND SNORE TRANSDUCER. Classified as Ventilatory Effort Recorder (product code MNR), Class II - Special Controls.

Submitted by Salter Labs (Arvin, US). The FDA issued a Cleared decision on September 15, 2005 after a review of 119 days - within the typical 510(k) review window.

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 - K051313

510(k) Number K051313 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 2005
Decision Date September 15, 2005
Days to Decision 119 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
21d faster than avg
Panel avg: 140d · This submission: 119d
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 151
Devices cleared under the same product code (MNR) and FDA review panel - the closest regulatory comparables to K051313.
MEDIBYTE, MODEL MP8
K061764 · Braebon Medical Corp. · Sep 2006
APNEALINK, MODEL 22302
K061405 · Resmed Germany, Inc. · Jul 2006
STARDUST II
K052573 · Respironics, Inc. · Dec 2005
LIFESCREEN APNEA
K042745 · Del Mar Reynolds Medical, Inc. · Jan 2005
WATCH PAT 100S
K042916 · Itamar Medical · Dec 2004
UNIVERSAL XACTTRACE
K043132 · Medcare Flaga · Dec 2004