Cleared Traditional

K101643 - MODEL LTV 1100 VENTILATOR

K101643 is an FDA 510(k) clearance for MODEL LTV 1100 VENTILATOR, manufactured by Care Fusion. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Traditional 510(k) pathway after a 230-day FDA review.

K101643 · Care Fusion · Anesthesiology device
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Jan 2011
Decision
230d
Days
Class 2
Risk

K101643 is an FDA 510(k) clearance for the MODEL LTV 1100 VENTILATOR. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Care Fusion (Vernon Hills, US). The FDA issued a Cleared decision on January 26, 2011 after a review of 230 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 Care Fusion devices

FDA 510(k) Submission Details - K101643

510(k) Number K101643 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 2010
Decision Date January 26, 2011
Days to Decision 230 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
90d slower than avg
Panel avg: 140d · This submission: 230d
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 319
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K101643.
ENGSTROM CARESTATION, ENGSTROM PRO, MODELS 1505-9000-000, 1505-9003-000
K111116 · Datex-Ohmeda · Sep 2011
AVEA VENTILATOR
K103211 · Care Fusion · May 2011
UNI-VENT 731 SERIES MODEL EMV+ PORTABLE CRITICAL CARE VENTILATOR
K103318 · Impact Instrumentation, Inc. · Apr 2011
HAMILTON-C2
K102775 · Hamilton Medical AG · Jan 2011
ESPRIT VENTILATOR WITH AF531 SE FULL FACE MASK
K101129 · Respironics, Inc. · Sep 2010
NEWPORT E360 VENTILATOR
K101803 · Newport Medical Instruments, Inc. · Sep 2010