Cleared Traditional

K810820 - CARDIOPULMONARY BYPASS

K810820 is the FDA 510(k) clearance for CARDIOPULMONARY BYPASS by Dlp, Inc.. It is a Class 2 Cardiovascular device (product code DWF) cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K810820 · Dlp, Inc. · Cardiovascular device
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Apr 1981
Decision
10d
Days
Class 2
Risk

K810820 is an FDA 510(k) clearance for the CARDIOPULMONARY BYPASS. Classified as Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), Class II - Special Controls.

Submitted by Dlp, Inc. (Walker, US). The FDA issued a Cleared decision on April 3, 1981 after a review of 10 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4210 - 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 Dlp, Inc. devices

Submission Details

510(k) Number K810820 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 1981
Decision Date April 03, 1981
Days to Decision 10 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
115d faster than avg
Panel avg: 125d · This submission: 10d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4210
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 - DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

All 231
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K810820.
KONTRON LITWAK-KOFFSKY OBTURATED CANNU
K821316 · Kontron Instruments, Inc. · Aug 1982
ARGYLE FERGUSON LEFT ATRIAL VENT CATH
K821445 · Sherwood Medical Co. · Jul 1982
SUBMISSION CORONARY CANNULA
K821149 · Dlp, Inc. · May 1982
SARNS TWO-STATE WIRE REINFORCED CATHETER
K810415 · 3M Health Care, Sarns · Mar 1981
CARDIOPULMINARY BYPASS CATHETER CANNULA
K810548 · Dlp, Inc. · Mar 1981
QUICK PRIME LINES, #'S BPL-12, BPL-48 &
K802378 · Bentley Laboratories, Inc. · Oct 1980