Cleared Traditional

K010642 - PLEURX PLEURAL CATHETER AND DRAINAGE KITS

K010642 is an FDA 510(k) clearance for PLEURX PLEURAL CATHETER AND DRAINAGE KITS, manufactured by Denver Biomedicals, Inc.. The device is a Class 2 Anesthesiology device with product code DWM cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K010642 · Denver Biomedicals, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2001
Decision
15d
Days
Class 2
Risk

K010642 is an FDA 510(k) clearance for the PLEURX PLEURAL CATHETER AND DRAINAGE KITS. 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 March 20, 2001 after a review of 15 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.

FDA 510(k) Submission Details - K010642

510(k) Number K010642 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 2001
Decision Date March 20, 2001
Days to Decision 15 days
Submission Type Traditional
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
125d faster than avg
Panel avg: 140d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K010642.
PLEURX PLEURAL CATHETER KIT, MODEL 50-7000
K052436 · Denver Biomedical, Inc. · Oct 2005
DENVER PLEURX DRAINAGE KIT AND DENVER PLEURX VACUUM BOTTLE WITH DRAINAGE LINE
K051084 · Denver Biomedicals, Inc. · Jun 2005
MODIFICATION TO PLEURX PLEURAL CATHETER AND DRAINAGE KITS
K011831 · Denver Biomedical, Inc. · Jun 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
WILLIAM HARVEY VENTED MEDIASTINAL DRAIN
K803037 · C.R. Bard, Inc. · Feb 1981