Cleared Traditional

K944219 - SINGLE PASS BLOOD CARDIOPLEGIA SPBC SYSTEM COMPONENTS (FDA 510(k) Clearance)

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

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

Submission Details

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
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.

Device Classification

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 90
Devices cleared under the same product code (DTR) and FDA review panel - the closest regulatory comparables to K944219.
Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W
K252541 · Spectrum Medical S.R.L. · Mar 2026
Quantum Micro-Cardioplegia Delivery System
K240908 · Spectrum Medical , Ltd. · Jul 2025
VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set)
K250150 · Sorin Group Italia S.R.L. · May 2025
MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System Uncoated
K240190 · Medtronic · Feb 2024
Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M)
K223879 · Quara S.R.L. · Apr 2023
Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat Exchanger
K220110 · Qura S.R.L · May 2022