Cleared Traditional

K030341 - MODIFICATION TO INSPIRATION VENTILATOR ...

K030341 is an FDA 510(k) clearance for MODIFICATION TO INSPIRATION VENTILATOR ..., manufactured by eVent Medical, Ltd.. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Traditional 510(k) pathway after a 347-day FDA review.

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

FDA 510(k) Submission Details - K030341

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.

CBK Device Classification - Class 2, Special Controls

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 327
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K030341.
SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E
K040221 · Maquet Critical Care AB · Feb 2004
NEWPORT E500 WAVE VENTILATOR
K030780 · Newport Medical Instruments, Inc. · Jan 2004
ESPRIT VENTILATOR, MODEL V1000
K034040 · Respironics, Inc. · Jan 2004
RAPHAEL
K022679 · Hamilton Medical AG · Oct 2003
DATEX-OHMEDA 7900 VENTILATOR ENHANCEMENTS
K023366 · Datex-Ohmeda, Inc. · Oct 2003
IMAGE3 SE DISPOSABLE FULL FACE MASK
K023135 · Respironics, Inc. · Jan 2003