Cleared Traditional

K072590 - INSPIRATION

Also marketed or referenced as:
VENTILATOR SYSTEM, LS VENTILATOR SYSTEM, INFANT VENTILATOR SYSTEM AND INFANT LS VENTILATOR SYSTEM

K072590 is an FDA 510(k) clearance for INSPIRATION, manufactured by Event Medical, Inc.. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K072590 · Event Medical, Inc. · Anesthesiology device
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Optimized for regulatory review, auditing and printing
Jan 2008
Decision
112d
Days
Class 2
Risk

K072590 is an FDA 510(k) clearance for the INSPIRATION. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Event Medical, Inc. (Aliso Viejo, US). The FDA issued a Cleared decision on January 4, 2008 after a review of 112 days - within the typical 510(k) review window.

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, Inc. devices

FDA 510(k) Submission Details - K072590

510(k) Number K072590 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 2007
Decision Date January 04, 2008
Days to Decision 112 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
28d faster than avg
Panel avg: 140d · This submission: 112d
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 K072590.
MODIFICATION TO HAMILTON-G5
K081521 · Hamilton Medical AG · Sep 2008
MODIFICATION TO GALILEO GOLD
K080181 · Hamilton Medical AG · Jun 2008
SERVO-I VENTILATOR SYSTEM MODEL 64 87 800 E4073, HELIOX OPTION, MODEL 6675585
K073179 · Maquet Critical Care AB · Jun 2008
PERFORMAX SE TOTAL FACE MASK
K072588 · Respironics Inc., Sleep & Home Respiratory Group · Dec 2007
HAMILTON-G5
K070513 · Hamilton Medical AG · Nov 2007
RAPHAEL COLOR ASV VENTILATOR
K071194 · Hamilton Medical AG · Oct 2007