Cleared Special

K002881 - VENTILATOR, CONTINUOUS (RESPIRATOR), MODEL LTV 1000 (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K002881 · Pulmonetic Systems, Inc. · Anesthesiology device
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Oct 2000
Decision
26d
Days
Class 2
Risk

K002881 is an FDA 510(k) clearance for the VENTILATOR, CONTINUOUS (RESPIRATOR), MODEL LTV 1000. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Pulmonetic Systems, Inc. (Colton, US). The FDA issued a Cleared decision on October 11, 2000 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5895 - the FDA anesthesiology and respiratory device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Pulmonetic Systems, Inc. devices

Submission Details

510(k) Number K002881 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received September 15, 2000
Decision Date October 11, 2000
Days to Decision 26 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
113d faster than avg
Panel avg: 139d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

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

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