Cleared Traditional

UNI-VENT MODEL 73X

K051476 · Impact Instrumentation, Inc. · Anesthesiology
Oct 2005
Decision
147d
Days
Class 2
Risk

About This 510(k) Submission

K051476 is an FDA 510(k) clearance for the UNI-VENT MODEL 73X, a Ventilator, Emergency, Powered (resuscitator) (Class II — Special Controls, product code BTL), submitted by Impact Instrumentation, Inc. (West Caldwell, US). The FDA issued a Cleared decision on October 28, 2005, 147 days after receiving the submission on June 3, 2005. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5925.

Submission Details

510(k) Number K051476 FDA.gov
FDA Decision Cleared SESE
Date Received June 03, 2005
Decision Date October 28, 2005
Days to Decision 147 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

Device Classification

Product Code BTL — Ventilator, Emergency, Powered (resuscitator)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5925

Similar Devices — BTL Ventilator, Emergency, Powered (resuscitator)

All 99
VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031)
K242769 · Draegerwerk AG & CO Kgaa · Apr 2025
Oxymag - Transport and Emergency Ventilator
K221634 · Magnamed Tecnologia Medica S/A · May 2023
VORTRAN GO2VENT with PEEP Valve
K202219 · Vortran Medical Technology 1, Inc. · Feb 2021
MEDUMAT Easy CPR, MEDUMAT Easy CPR with bag
K193191 · Weinmann Emergency Medical Technology GmbH + Co. KG · Nov 2020
Puffin Lite Infant Resuscitation System
K182956 · International Biomedical · Jan 2019
SafeT T-Piece Resuscitator
K173373 · Ventlab, LLC · Nov 2018