Cleared Traditional

K993062 - CHEST DRAINAGE TUBING

K993062 is an FDA 510(k) clearance for CHEST DRAINAGE TUBING, manufactured by Olson Medical Sales, Inc.. The device is a Class 2 Cardiovascular device with product code DWE cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K993062 · Olson Medical Sales, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1999
Decision
88d
Days
Class 2
Risk

K993062 is an FDA 510(k) clearance for the CHEST DRAINAGE TUBING. Classified as Tubing, Pump, Cardiopulmonary Bypass (product code DWE), Class II - Special Controls.

Submitted by Olson Medical Sales, Inc. (Somerset, US). The FDA issued a Cleared decision on December 10, 1999 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4390 - the FDA cardiovascular device oversight 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 Olson Medical Sales, Inc. devices

FDA 510(k) Submission Details - K993062

510(k) Number K993062 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 1999
Decision Date December 10, 1999
Days to Decision 88 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 125d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DWE Device Classification - Class 2, Special Controls

Product Code DWE Tubing, Pump, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4390
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DWE Tubing, Pump, Cardiopulmonary Bypass

All 14
Devices cleared under the same product code (DWE) and FDA review panel - the closest regulatory comparables to K993062.
PUMP TUBING WITH X-COATING
K022857 · Terumo Cardiovascular Systems Corporation · Sep 2002
PUMP TUBING
K013578 · Terumo Cardiovascular Systems Corp. · Jan 2002
CARDIOPULMONARY BYPASS PUMP TUBING - 1/4 INCH TUBING, CARDIOPULMONARY BYPASS PUMP TUBING - 3/8 INCH TUBING
K993189 · Terumo Corp. · Mar 2000
COBE SMARXT TUBING AND CONNECTORS
K981613 · Cobe Cardiovascular, Inc. · Oct 1998
SARNS TEMPERATURE PROBE AND CONNECTOR
K905686 · 3M Health Care, Sarns · Feb 1991
SARNS EVACUPLEGE CATHETER
K842044 · 3M Health Care, Sarns · Aug 1984