Cleared Traditional

K071095 - ASPIRA PLEURAL DRAINAGE SYSTEM

K071095 is an FDA 510(k) clearance for ASPIRA PLEURAL DRAINAGE SYSTEM, manufactured by Bard Access Systems, Inc.. The device is a Class 2 Anesthesiology device with product code DWM cleared through the Traditional 510(k) pathway after a 30-day FDA review.

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

FDA 510(k) Submission Details - K071095

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
110d faster than avg
Panel avg: 140d · This submission: 30d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

DWM Device Classification - Class 2, Special Controls

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.

Regulatory Consultant

Citech
BRADLEY BONNETTE

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DWM Apparatus, Suction, Patient Care

All 15
Devices cleared under the same product code (DWM) and FDA review panel - the closest regulatory comparables to K071095.
PLEURX PLEURAL CATHETER SYSTEMS
K112831 · Care Fusion · Feb 2012
ASPIRA PLEURAL DRAINAGE SYSTEM
K110409 · C.R. Bard, Inc. · May 2011
ASEPT PLEURAL DRAINAGE SYSTEM
K093307 · Pfm Medical, Inc. · Nov 2009
DENVER PLEURX DRAINAGE KIT AND DENVER PLEURX VACUUM BOTTLE WITH DRAINAGE LINE
K051084 · Denver Biomedicals, Inc. · Jun 2005
DENVER PLEURX PLEURAL CATHETER KIT, CATALOG NO. 50-7000, DENVER PLEURX HOME DRAINAGE KIT, CATALOG NO. 50-7500
K971753 · Denver Biomaterials, Inc. · Jun 1997
WILLIAM HARVEY VENTED MEDIASTINAL DRAIN
K803037 · C.R. Bard, Inc. · Feb 1981