BreatheBand® (Model 1000)— 510(k) K250860

Substantially Equivalent

Exemplar Medical, LLC

FDA 510(k) clearance K250860 for BreatheBand® (Model 1000), Substantially Equivalent on 2025-10-02. Applicant: Exemplar Medical, LLC.

Clearance details

Applicant: Exemplar Medical, LLC
Product code: Code BYI
Advisory panel: Anesthesiology
Date received: 2025-03-21
Decision date: 2025-10-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kansas City, MO, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code BYI

product code BYI

Death: 3
Total: 3

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.