Cleared Traditional

K202219 - VORTRAN GO2VENT with PEEP Valve

K202219 is an FDA 510(k) clearance for VORTRAN GO2VENT with PEEP Valve, manufactured by Vortran Medical Technology 1, Inc.. The device is a Class 2 Anesthesiology device with product code BTL cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K202219 · Vortran Medical Technology 1, Inc. · Anesthesiology device
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Feb 2021
Decision
189d
Days
Class 2
Risk

K202219 is an FDA 510(k) clearance for the VORTRAN GO2VENT with PEEP Valve. Classified as Ventilator, Emergency, Powered (resuscitator) (product code BTL), Class II - Special Controls.

Submitted by Vortran Medical Technology 1, Inc. (Sacramento, US). The FDA issued a Cleared decision on February 11, 2021 after a review of 189 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5925 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Vortran Medical Technology 1, Inc. devices

FDA 510(k) Submission Details - K202219

510(k) Number K202219 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2020
Decision Date February 11, 2021
Days to Decision 189 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
49d slower than avg
Panel avg: 140d · This submission: 189d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTL Device Classification - Class 2, Special Controls

Product Code BTL Ventilator, Emergency, Powered (resuscitator)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5925
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - BTL Ventilator, Emergency, Powered (resuscitator)

All 31
Devices cleared under the same product code (BTL) and FDA review panel - the closest regulatory comparables to K202219.
VentStar Resus heated (N) (MP17030)
K242769 · Draegerwerk AG & CO Kgaa · Apr 2025
Oxymag - Transport and Emergency Ventilator
K221634 · Magnamed Tecnologia Medica S/A · May 2023
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
VORTRAN GO2VENT
K162968 · Vortran Medical Technology 1, Inc. · Apr 2017