Cleared Traditional

K260604 - BiWaze Clear System

K260604 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 181-day FDA review.

K260604 · Abmrc, LLC · Anesthesiology device
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Aug 2026
Decision
181d
Days
Class 2
Risk

K260604 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 August 24, 2026 after a review of 181 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 - K260604

510(k) Number K260604 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 2026
Decision Date August 24, 2026
Days to Decision 181 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
41d slower than avg
Panel avg: 140d · This submission: 181d
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 Consultant

ProMedic Consulting, LLC
Paul Dryden

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - NHJ Device, Positive Pressure Breathing, Intermittent

All 22
Devices cleared under the same product code (NHJ) and FDA review panel - the closest regulatory comparables to K260604.
KT Airway Clearance Device II (KT-3)
K253001 · Hunan Ruijiong Biotech Co., Ltd. · Jun 2026
Clearo
K242438 · Breas Medical AB · May 2025
BiWaze Clear System
K231728 · Abmrc, LLC · Apr 2024
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