Cleared Traditional

K021112 - INSPIRATION VENTILATOR SYSTEM

K021112 is an FDA 510(k) clearance for INSPIRATION VENTILATOR SYSTEM, 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 231-day FDA review.

K021112 · eVent Medical, Ltd. · Anesthesiology device
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Nov 2002
Decision
231d
Days
Class 2
Risk

K021112 is an FDA 510(k) clearance for the INSPIRATION VENTILATOR SYSTEM. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by eVent Medical, Ltd. (Carlsbad, US). The FDA issued a Cleared decision on November 22, 2002 after a review of 231 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

FDA 510(k) Submission Details - K021112

510(k) Number K021112 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 2002
Decision Date November 22, 2002
Days to Decision 231 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
91d slower than avg
Panel avg: 140d · This submission: 231d
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 K021112.
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
BIRD AVEA VENTILATOR
K022674 · Bird Products Corp. · Nov 2002
SERVO VENTILATOR SYSTEM, MODEL 64 87 800 E407E
K022132 · Siemens Medical Solutions USA, Inc. · Sep 2002
AVEA
K013642 · Bird Products Corp. · May 2002