Cleared Traditional

VERSALVENT MODEL V1 HYPERBARIC CHAMBER VENTILATOR MODEL V1 (K122560) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K122560 · Pan-America Hyperbarics, Inc. · Anesthesiology device
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Mar 2013
Decision
216d
Days
Class 2
Risk

K122560 is an FDA 510(k) clearance for the VERSALVENT MODEL V1 HYPERBARIC CHAMBER VENTILATOR MODEL V1. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Pan-America Hyperbarics, Inc. (Atchison, US). The FDA issued a Cleared decision on March 26, 2013 after a review of 216 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5895 - 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 Pan-America Hyperbarics, Inc. devices

Submission Details

510(k) Number K122560 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 2012
Decision Date March 26, 2013
Days to Decision 216 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
76d slower than avg
Panel avg: 140d · This submission: 216d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CBK Ventilator, Continuous, Facility Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5895
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 - CBK Ventilator, Continuous, Facility Use

All 64
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K122560.
Puritan Bennett 980 Ventilator System
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AF541 SE Full Face Mask
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PURITAN BENNETT 980 SERIES VENTILATOR SYSTEM
K131252 · Covidien · Feb 2014
PERFORMAX PEDIATRIC SE TOTAL FACE MASK
K120639 · Respironics, Inc. · Jul 2012
TRILOGY SERIES VENTILATOR WITH OXIMETRY
K111610 · Respironics, Inc. · Oct 2011
ESPRIT VENTILATOR WITH AF531 SE FULL FACE MASK
K101129 · Respironics, Inc. · Sep 2010