Cleared Special

K010608 - MODIFICATION TO LAP TOP VENTILATOR (LTV)

K010608 is an FDA 510(k) clearance for MODIFICATION TO LAP TOP VENTILATOR (LTV), manufactured by Pulmonetic Systems, Inc.. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Special 510(k) pathway after a 19-day FDA review.

K010608 · Pulmonetic Systems, Inc. · Anesthesiology device
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Mar 2001
Decision
19d
Days
Class 2
Risk

K010608 is an FDA 510(k) clearance for the MODIFICATION TO LAP TOP VENTILATOR (LTV). 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 March 20, 2001 after a review of 19 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

FDA 510(k) Submission Details - K010608

510(k) Number K010608 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2001
Decision Date March 20, 2001
Days to Decision 19 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
121d faster than avg
Panel avg: 140d · This submission: 19d
Pathway characteristics
Modification to existing cleared device.

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 K010608.
AVEA
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K001646 · Puritan Bennett Corp. · Oct 2000
ACHIEVA VENTILATOR Y-ACH+E, ACHIEVA PS VENTILATOR Y-ACHPS+E, ACHIEVA PSO2 VENTILATOR Y-ACHPS02+E
K002686 · Nellcor Puritan Bennett, Inc. · Oct 2000