Cleared Traditional

CARDIOPULMINARY BYPASS CATHETER CANNULA (K810548) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K810548 · Dlp, Inc. · Cardiovascular device

Download Printable Device Report (PDF)

Optimized for regulatory review, auditing and printing

Mar 1981

Decision

15d

Days

Class 2

Risk

K810548 is an FDA 510(k) clearance for the CARDIOPULMINARY BYPASS CATHETER CANNULA. 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 March 17, 1981 after a review of 15 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	K810548 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 02, 1981
Decision Date	March 17, 1981
Days to Decision	15 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	-
Third-party Review	No - reviewed directly by FDA

Regulatory Context

Review time vs. panel average

110d faster than avg

Panel avg: 125d · This submission: 15d

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 103

Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K810548.

ARGYLE DUAL STAGE VENOUS RETURN CATH.

K831332 · Sherwood Medical Co. · Jun 1983

ARGYLE CAROTID ARTERY LOOP SHUNT

K822317 · Sherwood Medical Co. · Aug 1982

ARGYLE FERGUSON LEFT ATRIAL VENT CATH

K821445 · Sherwood Medical Co. · Jul 1982

SHILEY CARDIOPLEGIC SOLUTION DEL SETS

K791947 · Shiley, Inc. · Nov 1979

CARDIOPLEGIA ADMIN. SETS

K791858 · Travenol Laboratories, S.A. · Oct 1979

ARGYLE PEDIATRIC VENA CAVAL CATHETER

K791972 · Sherwood Medical Co. · Oct 1979

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K810548

Dlp, Inc.

Walker, MI · US

Regulatory profile

56 submissions 56 cleared

100% clearance rate · Active in Cardiovascular

Data Intelligence Layer

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

Verify on FDA.gov

510k Database

510(k) clearances indexed 175,218

Regulatory data since 1976

FDA monthly sync Active