InstaFAN— 510(k) K251542

Substantially Equivalent

Onepass Medical , Ltd.

FDA 510(k) clearance K251542 for InstaFAN, Substantially Equivalent on 2025-07-18. Applicant: Onepass Medical , Ltd..

Clearance details

Applicant: Onepass Medical , Ltd.
Product code: Code ODG
Advisory panel: Gastroenterology, Urology
Date received: 2025-05-20
Decision date: 2025-07-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Katzrin, IL

Download summary PDF View on FDA.gov ↗

Adverse events under product code ODG

product code ODG

Death: 30
Injury: 237
Malfunction: 12,387
Other: 1
Total: 12,655

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.