BiWaze Clear System— 510(k) K260604
Substantially EquivalentAbmrc, LLC
FDA 510(k) clearance K260604 for BiWaze Clear System, Substantially Equivalent on 2026-08-24. Applicant: Abmrc, LLC. Device class: 2.
Summary
ABMRC's BiWaze Clear System is filed under product code NHJ, intermittent positive pressure breathing devices. No model numbers are listed.
Class II, 21 CFR 868.5905. Anesthesiology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
ABMRC filed from Eagan, Minnesota. Review took 181 calendar days (February 24 to August 24, 2026), ending in a substantially equivalent decision.
Clearance details
- Applicant
- Abmrc, LLC
- Product code
- Product code NHJ
- Device class
- Class 2
- Regulation
- 21 CFR 868.5905
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Eagan, MN, US
Recent devices under product code NHJ
view allMore clearances from Abmrc, LLC
view allAdverse events under product code NHJ
product code NHJ- Death
- 7
- Total
- 7
Source: openFDA MAUDE database, through . 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.