Cleared Special

K011831 - MODIFICATION TO PLEURX PLEURAL CATHETER AND DRAINAGE KITS (FDA 510(k) Clearance)

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

K011831 · Denver Biomedical, Inc. · Anesthesiology device
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Jun 2001
Decision
16d
Days
Class 2
Risk

K011831 is an FDA 510(k) clearance for the MODIFICATION TO PLEURX PLEURAL CATHETER AND DRAINAGE KITS. Classified as Apparatus, Suction, Patient Care (product code DWM), Class II - Special Controls.

Submitted by Denver Biomedical, Inc. (Golden, US). The FDA issued a Cleared decision on June 28, 2001 after a review of 16 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 870.5050 - 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 Denver Biomedical, Inc. devices

Submission Details

510(k) Number K011831 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 2001
Decision Date June 28, 2001
Days to Decision 16 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
123d faster than avg
Panel avg: 139d · This submission: 16d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code DWM Apparatus, Suction, Patient Care
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5050
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.