Cleared Traditional

K902845 - GENTLE HEADER

K902845 is an FDA 510(k) clearance for GENTLE HEADER, manufactured by Enhanced Perfusion Systems, Inc.. The device is a Class 2 Cardiovascular device with product code DWE cleared through the Traditional 510(k) pathway after a 158-day FDA review.

K902845 · Enhanced Perfusion Systems, Inc. · Cardiovascular device
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Dec 1990
Decision
158d
Days
Class 2
Risk

K902845 is an FDA 510(k) clearance for the GENTLE HEADER. Classified as Tubing, Pump, Cardiopulmonary Bypass (product code DWE), Class II - Special Controls.

Submitted by Enhanced Perfusion Systems, Inc. (Grass Lake, US). The FDA issued a Cleared decision on December 3, 1990 after a review of 158 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Enhanced Perfusion Systems, Inc. devices

FDA 510(k) Submission Details - K902845

510(k) Number K902845 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 1990
Decision Date December 03, 1990
Days to Decision 158 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d slower than avg
Panel avg: 125d · This submission: 158d
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 17
Devices cleared under the same product code (DWE) and FDA review panel - the closest regulatory comparables to K902845.
CHEST DRAINAGE TUBING
K993062 · Olson Medical Sales, Inc. · Dec 1999
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
MEDRAD HIGH PRESSURE CONECTING TUBE
K810924 · Medrad, Inc. · Apr 1981
TYGON TUBING
K803277 · Electromedics, Inc. · Jan 1981