SafeT T-Piece Resuscitator— 510(k) K173373

Substantially Equivalent

Ventlab, LLC

FDA 510(k) clearance K173373 for SafeT T-Piece Resuscitator, Substantially Equivalent on 2018-11-16. Applicant: Ventlab, LLC.

Clearance details

Applicant: Ventlab, LLC
Product code: Code BTL
Advisory panel: Anesthesiology
Date received: 2017-10-27
Decision date: 2018-11-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Grand Rapids, MI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code BTL

product code BTL

Death: 8
Malfunction: 3,256
Other: 1
Total: 3,265

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.