SafeT T-Piece Resuscitator— 510(k) K173373

Name: FDA 510(k) clearance K173373
Creator: U.S. Food and Drug Administration
Published: 2018-11-16

Substantially Equivalent

Ventlab, LLC

FDA 510(k) clearance K173373 for SafeT T-Piece Resuscitator, Substantially Equivalent on 2018-11-16. Applicant: Ventlab, LLC. Device class: 2.

Clearance details

Applicant: Ventlab, LLC
Product code: Code BTL
Device class: Class 2
Regulation: 21 CFR 868.5925
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 ↗

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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.