Cleared Traditional

INSPIRATION VENTILATOR SYSTEM 5I/7I (K130178) - FDA 510(k) Clearance

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

K130178 · eVent Medical, Ltd. · Anesthesiology device
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Oct 2013
Decision
277d
Days
Class 2
Risk

K130178 is an FDA 510(k) clearance for the INSPIRATION VENTILATOR SYSTEM 5I/7I. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by eVent Medical, Ltd. (San Clemente, US). The FDA issued a Cleared decision on October 29, 2013 after a review of 277 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 eVent Medical, Ltd. devices

Submission Details

510(k) Number K130178 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 2013
Decision Date October 29, 2013
Days to Decision 277 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
137d slower than avg
Panel avg: 140d · This submission: 277d
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 K130178.
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K101129 · Respironics, Inc. · Sep 2010