Cleared Traditional

K944219 - SINGLE PASS BLOOD CARDIOPLEGIA SPBC SYS...

K944219 is an FDA 510(k) clearance for SINGLE PASS BLOOD CARDIOPLEGIA SPBC SYS..., manufactured by Gish Biomedical, Inc.. The device is a Class 2 Cardiovascular device with product code DTR cleared through the Traditional 510(k) pathway after a 305-day FDA review.

K944219 · Gish Biomedical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1995
Decision
305d
Days
Class 2
Risk

K944219 is an FDA 510(k) clearance for the SINGLE PASS BLOOD CARDIOPLEGIA SPBC SYSTEM COMPONENTS. Classified as Heat-exchanger, Cardiopulmonary Bypass (product code DTR), Class II - Special Controls.

Submitted by Gish Biomedical, Inc. (Irvine, US). The FDA issued a Cleared decision on June 30, 1995 after a review of 305 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4240 - 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. Elevated predicate reliance profile. 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 Gish Biomedical, Inc. devices

FDA 510(k) Submission Details - K944219

510(k) Number K944219 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 1994
Decision Date June 30, 1995
Days to Decision 305 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
180d slower than avg
Panel avg: 125d · This submission: 305d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTR Device Classification - Class 2, Special Controls

Product Code DTR Heat-exchanger, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4240
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 - DTR Heat-exchanger, Cardiopulmonary Bypass

All 82
Devices cleared under the same product code (DTR) and FDA review panel - the closest regulatory comparables to K944219.
CARMEDA COATED CARDIOTHERM BLOOD CARDIOPLEGIA SYSTEMS (CBCTXXX SERIES AND CBCTXXXBR SERIES)
K973475 · Medtronic Vascular · Nov 1997
VISION CARDIOPLEGIA DELIVERY SYSTEM
K964571 · Lifestream Int'L, Inc. · Aug 1997
MYOCARDIAL PROTECTION SYSTEM
K953838 · Quest Medical, Inc. · Mar 1996
HEAT EXCHANGER MODIFICATION FOR DUO AND OPTIMA
K944267 · Cobe Cardiovascular, Inc. · Apr 1995
ELECTROMEDICS BLOOD HEAT EXCHANGER
K934355 · Electromedics, Inc. · Dec 1993
ROTATOR
K932251 · Merit Medical Systems, Inc. · Aug 1993