Cleared Traditional

K781990 - CARDIAC INSULATION PAD

K781990 is an FDA 510(k) clearance for CARDIAC INSULATION PAD, manufactured by Shiley, Inc.. The device is a Class 2 Cardiovascular device with product code DWF cleared through the Traditional 510(k) pathway after a 7-day FDA review.

K781990 · Shiley, Inc. · Cardiovascular device
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Dec 1978
Decision
7d
Days
Class 2
Risk

K781990 is an FDA 510(k) clearance for the CARDIAC INSULATION PAD. Classified as Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), Class II - Special Controls.

Submitted by Shiley, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 4, 1978 after a review of 7 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 Shiley, Inc. devices

FDA 510(k) Submission Details - K781990

510(k) Number K781990 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 1978
Decision Date December 04, 1978
Days to Decision 7 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
118d faster than avg
Panel avg: 125d · This submission: 7d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DWF Device Classification - Class 2, Special Controls

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 283
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K781990.
ARGYLE PEDIATRIC VENA CAVAL CATHETER
K791972 · Sherwood Medical Co. · Oct 1979
AORTIC ROOT CANNULA
K790565 · Dlp, Inc. · Jun 1979
SARNS WIRE-REINFORCED VENOUS RETURN CAN
K790246 · 3M Health Care, Sarns · Mar 1979
TUBING SETS
K771692 · Cobe Laboratories, Inc. · Oct 1977
FLEXIBLE ARTERIAL CANNULAE
K771499 · 3M Health Care, Sarns · Aug 1977
CANNULAE, AORTIC, ARCH, HIGH FLOW
K770429 · 3M Health Care, Sarns · Mar 1977