BiWaze Clear System— 510(k) K260604

Name: FDA 510(k) clearance K260604
Creator: U.S. Food and Drug Administration
Published: 2026-08-24

Substantially Equivalent

Abmrc, LLC

FDA 510(k) clearance K260604 for BiWaze Clear System, Substantially Equivalent on 2026-08-24. Applicant: Abmrc, LLC. Device class: 2.

Clearance details

Applicant: Abmrc, LLC
Product code: Code NHJ
Device class: Class 2
Regulation: 21 CFR 868.5905
Advisory panel: Anesthesiology
Date received: 2026-02-24
Decision date: 2026-08-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eagan, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code NHJ

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K253001 — KT Airway Clearance Device II (KT-3); KT Airway Clearance Device II (KT-5)2026-06-16
K242438 — Clearo2025-05-16
K231728 — BiWaze Clear System2024-04-08
K213564 — BiWaze Clear System2022-12-21
K200988 — Maximus System2020-05-26

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K191912 — BiWaze Cough2020-03-27

Adverse events under product code NHJ

product code NHJ

Death: 7
Total: 7

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.