Cleared Traditional

K231728 - BiWaze Clear System

K231728 is an FDA 510(k) clearance for BiWaze Clear System, 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 300-day FDA review.

K231728 · Abmrc, LLC · Anesthesiology device
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Apr 2024
Decision
300d
Days
Class 2
Risk

K231728 is an FDA 510(k) clearance for the BiWaze Clear System. Classified as Device, Positive Pressure Breathing, Intermittent (product code NHJ), Class II - Special Controls.

Submitted by Abmrc, LLC (Eagan, US). The FDA issued a Cleared decision on April 8, 2024 after a review of 300 days - an unusually long review period, suggesting complex equivalence evaluation.

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 - K231728

510(k) Number K231728 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 2023
Decision Date April 08, 2024
Days to Decision 300 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
160d slower than avg
Panel avg: 140d · This submission: 300d
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 K231728.
Clearo
K242438 · Breas Medical AB · May 2025
BiWaze Clear System
K213564 · Abmrc, LLC · Dec 2022
Maximus System
K200988 · Hill-Rom Services Pte, Ltd. · May 2020
BiWaze Cough
K191912 · Abmrc, LLC · Mar 2020
Maximus System
K192143 · Hill-Rom Services Pte, Ltd. · Feb 2020
COUGHASSIST T70 DEVICE
K121955 · Respironics, Inc. · Dec 2012