Cleared Traditional

BCD PLUS BLOOD CARDIOPLEGIA SYS(HEREAF REFER DEV) (K852780) - FDA 510(k) Clearance

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

K852780 · Shiley, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1985
Decision
91d
Days
Class 2
Risk

K852780 is an FDA 510(k) clearance for the BCD PLUS BLOOD CARDIOPLEGIA SYS(HEREAF REFER DEV). 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 30, 1985 after a review of 91 days - within the typical 510(k) review window.

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. 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 Shiley, Inc. devices

Submission Details

510(k) Number K852780 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1985
Decision Date September 30, 1985
Days to Decision 91 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
34d faster than avg
Panel avg: 125d · This submission: 91d
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 K852780.
SHILEY BCD PLUS HEAT EXCHANGER
K880663 · Shiley, Inc. · May 1988
STOCKERT-SHILEY HEATER/COOLER TEMPERATURE CONTROL
K860920 · Shiley, Inc. · May 1986
MODEL 492-03 POLYFLEX IMPLANTABLE PACING LEAD
K853410 · Intermedics, Inc. · Oct 1985
LAL TEST RELEASE & BONCHEK CAR/JACKET
K833555 · Shiley, Inc. · Feb 1984
JACKET & SET
K823533 · Shiley, Inc. · Dec 1982
BRONCHEK-SHILEY CARDIAC JACKET & BSC J
K811204 · Shiley, Inc. · May 1981