Cleared Traditional

K191912 - BiWaze Cough

K191912 is an FDA 510(k) clearance for BiWaze Cough, manufactured by Abmrc, LLC. The device is a Class 2 Anesthesiology device with product code NHJ cleared through the Traditional 510(k) pathway after a 254-day FDA review.

K191912 · Abmrc, LLC · Anesthesiology device
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Mar 2020
Decision
254d
Days
Class 2
Risk

K191912 is an FDA 510(k) clearance for the BiWaze Cough. Classified as Device, Positive Pressure Breathing, Intermittent (product code NHJ), Class II - Special Controls.

Submitted by Abmrc, LLC (Charleston, US). The FDA issued a Cleared decision on March 27, 2020 after a review of 254 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5905 - 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 Abmrc, LLC devices

FDA 510(k) Submission Details - K191912

510(k) Number K191912 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 2019
Decision Date March 27, 2020
Days to Decision 254 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
114d slower than avg
Panel avg: 140d · This submission: 254d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NHJ Device Classification - Class 2, Special Controls

Product Code NHJ Device, Positive Pressure Breathing, Intermittent
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5905
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 - NHJ Device, Positive Pressure Breathing, Intermittent

All 11
Devices cleared under the same product code (NHJ) and FDA review panel - the closest regulatory comparables to K191912.
BiWaze Clear System
K231728 · Abmrc, LLC · Apr 2024
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Maximus System
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Maximus System
K192143 · Hill-Rom Services Pte, Ltd. · Feb 2020
COUGHASSIST T70 DEVICE
K121955 · Respironics, Inc. · Dec 2012
PERCUSSIVENEB, MODEL PN-2001
K003684 · Vortran Medical Technology 1, Inc. · Feb 2001