Cleared Traditional

BiWaze Clear System (K231728) - FDA 510(k) Clearance

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

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

Submission Details

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.

Device Classification

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

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