Cleared Traditional

MODIFICATION TO INSPIRATION VENTILATOR SYSTEM (K030341) - FDA 510(k) Clearance

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

K030341 · eVent Medical, Ltd. · Anesthesiology device
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Jan 2004
Decision
347d
Days
Class 2
Risk

K030341 is an FDA 510(k) clearance for the MODIFICATION TO INSPIRATION VENTILATOR SYSTEM. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by eVent Medical, Ltd. (Galway, IE). The FDA issued a Cleared decision on January 16, 2004 after a review of 347 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 K030341 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 2003
Decision Date January 16, 2004
Days to Decision 347 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
207d slower than avg
Panel avg: 140d · This submission: 347d
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 K030341.
TRILOGY 202 VENTILATOR
K093905 · Respironics, Inc. · May 2010
TRILOGY 200 VENTILATOR
K093416 · Respironics, Inc. · Jan 2010
ESPRIT VENTILATOR, MODEL V1000
K034040 · Respironics, Inc. · Jan 2004
IMAGE3 SE DISPOSABLE FULL FACE MASK
K023135 · Respironics, Inc. · Jan 2003
SERVO VENTILATOR SYSTEM, MODEL 64 87 800 E407E
K022132 · Siemens Medical Solutions USA, Inc. · Sep 2002
ESPIRT
K001208 · Respironics, Inc. · May 2000