Cleared Traditional

K971753 - DENVER PLEURX PLEURAL CATHETER KIT, CATALOG NO. 50-7000, DENVER PLEURX HOME DRAINAGE KIT, CATALOG NO. 50-7500

K971753 is an FDA 510(k) clearance for DENVER PLEURX PLEURAL CATHETER KIT, manufactured by Denver Biomaterials, Inc.. The device is a Class 2 Anesthesiology device with product code DWM cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K971753 · Denver Biomaterials, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1997
Decision
46d
Days
Class 2
Risk

K971753 is an FDA 510(k) clearance for the DENVER PLEURX PLEURAL CATHETER KIT, CATALOG NO. 50-7000, DENVER PLEURX HOME D.... Classified as Apparatus, Suction, Patient Care (product code DWM), Class II - Special Controls.

Submitted by Denver Biomaterials, Inc. (Golden, US). The FDA issued a Cleared decision on June 27, 1997 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. 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 Denver Biomaterials, Inc. devices

FDA 510(k) Submission Details - K971753

510(k) Number K971753 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received May 12, 1997
Decision Date June 27, 1997
Days to Decision 46 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
94d faster than avg
Panel avg: 140d · This submission: 46d
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.