Cleared Traditional

K803277 - TYGON TUBING

K803277 is the FDA 510(k) clearance for TYGON TUBING by Electromedics, Inc.. It is a Class 2 Cardiovascular device (product code DWE) cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K803277 · Electromedics, Inc. · Cardiovascular device
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Jan 1981
Decision
15d
Days
Class 2
Risk

K803277 is an FDA 510(k) clearance for the TYGON TUBING. Classified as Tubing, Pump, Cardiopulmonary Bypass (product code DWE), Class II - Special Controls.

Submitted by Electromedics, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 13, 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 870.4390 - 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 Electromedics, Inc. devices

Submission Details

510(k) Number K803277 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 1980
Decision Date January 13, 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 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

Devices cleared under the same product code (DWE) and FDA review panel - the closest regulatory comparables to K803277.
SARNS TEMPERATURE PROBE AND CONNECTOR
K905686 · 3M Health Care, Sarns · Feb 1991
SARNS EVACUPLEGE CATHETER
K842044 · 3M Health Care, Sarns · Aug 1984
MEDRAD HIGH PRESSURE CONECTING TUBE
K810924 · Medrad, Inc. · Apr 1981
EXTRACORP.'S INTERSEPT CUS. TUBING PK.
K800178 · Extracorporeal Medical Specialities, Inc. · Feb 1980