Cleared Special

K051084 - DENVER PLEURX DRAINAGE KIT AND DENVER PLEURX VACUUM BOTTLE WITH DRAINAGE LINE

K051084 is an FDA 510(k) clearance for DENVER PLEURX DRAINAGE KIT AND DENVER P..., manufactured by Denver Biomedicals, Inc.. The device is a Class 2 Anesthesiology device with product code DWM cleared through the Special 510(k) pathway after a 46-day FDA review.

K051084 · Denver Biomedicals, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2005
Decision
46d
Days
Class 2
Risk

K051084 is an FDA 510(k) clearance for the DENVER PLEURX DRAINAGE KIT AND DENVER PLEURX VACUUM BOTTLE WITH DRAINAGE LINE. Classified as Apparatus, Suction, Patient Care (product code DWM), Class II - Special Controls.

Submitted by Denver Biomedicals, Inc. (Golden, US). The FDA issued a Cleared decision on June 13, 2005 after a review of 46 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.

FDA 510(k) Submission Details - K051084

510(k) Number K051084 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 2005
Decision Date June 13, 2005
Days to Decision 46 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 140d · This submission: 46d
Pathway characteristics
Modification to existing cleared device.

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 Peers - DWM Apparatus, Suction, Patient Care

All 18
Devices cleared under the same product code (DWM) and FDA review panel - the closest regulatory comparables to K051084.
ASEPT PLEURAL DRAINAGE SYSTEM
K093307 · Pfm Medical, Inc. · Nov 2009
ASPIRA PLEURAL DRAINAGE SYSTEM
K071095 · Bard Access Systems, Inc. · May 2007
PLEURX PLEURAL CATHETER KIT, MODEL 50-7000
K052436 · Denver Biomedical, Inc. · Oct 2005
MODIFICATION TO PLEURX PLEURAL CATHETER AND DRAINAGE KITS
K011831 · Denver Biomedical, Inc. · Jun 2001
PLEURX PLEURAL CATHETER AND DRAINAGE KITS
K010642 · Denver Biomedicals, Inc. · Mar 2001
DENVER PLEURX PLEURAL CATHETER KIT, CATALOG NO. 50-7000, DENVER PLEURX HOME DRAINAGE KIT, CATALOG NO. 50-7500
K971753 · Denver Biomaterials, Inc. · Jun 1997