Cleared Traditional

K071095 - ASPIRA PLEURAL DRAINAGE SYSTEM (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K071095 · Bard Access Systems, Inc. · Anesthesiology device
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May 2007
Decision
30d
Days
Class 2
Risk

K071095 is an FDA 510(k) clearance for the ASPIRA PLEURAL DRAINAGE SYSTEM. Classified as Apparatus, Suction, Patient Care (product code DWM), Class II - Special Controls.

Submitted by Bard Access Systems, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on May 18, 2007 after a review of 30 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Bard Access Systems, Inc. devices

Submission Details

510(k) Number K071095 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 2007
Decision Date May 18, 2007
Days to Decision 30 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
109d faster than avg
Panel avg: 139d · This submission: 30d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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.