Cleared Traditional

K880663 - SHILEY BCD PLUS HEAT EXCHANGER

K880663 is an FDA 510(k) clearance for SHILEY BCD PLUS HEAT EXCHANGER, manufactured by Shiley, Inc.. The device is a Class 2 Cardiovascular device with product code DTR cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K880663 · Shiley, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1988
Decision
83d
Days
Class 2
Risk

K880663 is an FDA 510(k) clearance for the SHILEY BCD PLUS HEAT EXCHANGER. 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 May 11, 1988 after a review of 83 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

FDA 510(k) Submission Details - K880663

510(k) Number K880663 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 1988
Decision Date May 11, 1988
Days to Decision 83 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
42d faster than avg
Panel avg: 125d · This submission: 83d
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 K880663.
BASIC HEATER-COOLER UNIT, 115/100V 16-02-20
K883330 · Shiley, Inc. · Sep 1988
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
SCIMED MODELS P-7-14 AND A-19-38 HEAT EXCHANGERS
K880451 · Scimed Life Systems, Inc. · Apr 1988
ELECTROMEDICS D1079E
K873561 · Electromedics, Inc. · Nov 1987
CARDIOPLEGIA HEAT EXCHANGER MODEL NO. HE-100
K870804 · American Bentley · Sep 1987