Cleared Traditional

BASIC HEATER-COOLER UNIT, 115/100V 16-02-20 (K883330) - FDA 510(k) Clearance

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

K883330 · Shiley, Inc. · Cardiovascular device
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Sep 1988
Decision
49d
Days
Class 2
Risk

K883330 is an FDA 510(k) clearance for the BASIC HEATER-COOLER UNIT, 115/100V 16-02-20. Classified as Heat-exchanger, Cardiopulmonary Bypass (product code DTR), Class II - Special Controls.

Submitted by Shiley, Inc. (Irvine, US). The FDA issued a Cleared decision on September 26, 1988 after a review of 49 days - a notably fast clearance cycle.

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: 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

Submission Details

510(k) Number K883330 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 1988
Decision Date September 26, 1988
Days to Decision 49 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
76d faster than avg
Panel avg: 125d · This submission: 49d
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 32
Devices cleared under the same product code (DTR) and FDA review panel - the closest regulatory comparables to K883330.
BCD ADVANCED
K910923 · Shiley, Inc. · Apr 1991
MODIFIED MP-4 CARDIOPLEGIA DELIVERY SYSTEM W/CONDU
K900640 · 3M Company · Apr 1990
SARNS MINIPRIME CARDIOPLEGIA SET W/CONDUCER(TM)
K897039 · 3M Company · Mar 1990
BASIC HEATER-COOLER UNIT W/MAST, 115/110V 16-21-10
K883331 · Shiley, Inc. · Sep 1988
MAST FOR BASIC HEATER-COOLER UNIT 16-09-00
K883332 · Shiley, Inc. · Sep 1988
SHILEY BCD PLUS HEAT EXCHANGER
K880663 · Shiley, Inc. · May 1988