Cleared Traditional

BRONCHEK-SHILEY CARDIAC JACKET & BSC J (K811204) - FDA 510(k) Clearance

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

K811204 · Shiley, Inc. · Cardiovascular device
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May 1981
Decision
20d
Days
Class 2
Risk

K811204 is an FDA 510(k) clearance for the BRONCHEK-SHILEY CARDIAC JACKET & BSC J. Classified as Heat-exchanger, Cardiopulmonary Bypass (product code DTR), Class II - Special Controls.

Submitted by Shiley, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 21, 1981 after a review of 20 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 K811204 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 1981
Decision Date May 21, 1981
Days to Decision 20 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
105d faster than avg
Panel avg: 125d · This submission: 20d
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 K811204.
BCD PLUS BLOOD CARDIOPLEGIA SYS(HEREAF REFER DEV)
K852780 · Shiley, Inc. · Sep 1985
LAL TEST RELEASE & BONCHEK CAR/JACKET
K833555 · Shiley, Inc. · Feb 1984
JACKET & SET
K823533 · Shiley, Inc. · Dec 1982
BUCKBERG-SHILEY BLOOD CARDIOPLEGIC SPL.
K802879 · Shiley, Inc. · Dec 1980
MINIPRIME HYPOTHERMIC HEAT EXCHANGER
K791430 · Travenol Laboratories, S.A. · Aug 1979