Cleared Traditional

LAL TEST RELEASE & BONCHEK CAR/JACKET (K833555) - FDA 510(k) Clearance

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

K833555 · Shiley, Inc. · Cardiovascular device
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Feb 1984
Decision
110d
Days
Class 2
Risk

K833555 is an FDA 510(k) clearance for the LAL TEST RELEASE & BONCHEK CAR/JACKET. Classified as Heat-exchanger, Cardiopulmonary Bypass (product code DTR), Class II - Special Controls.

Submitted by Shiley, Inc. (Walker, US). The FDA issued a Cleared decision on February 4, 1984 after a review of 110 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 K833555 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 1983
Decision Date February 04, 1984
Days to Decision 110 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
15d faster than avg
Panel avg: 125d · This submission: 110d
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 K833555.
STOCKERT-SHILEY HEATER/COOLER TEMPERATURE CONTROL
K860920 · Shiley, Inc. · May 1986
MODEL 492-03 POLYFLEX IMPLANTABLE PACING LEAD
K853410 · Intermedics, Inc. · Oct 1985
BCD PLUS BLOOD CARDIOPLEGIA SYS(HEREAF REFER DEV)
K852780 · Shiley, Inc. · Sep 1985
JACKET & SET
K823533 · Shiley, Inc. · Dec 1982
BRONCHEK-SHILEY CARDIAC JACKET & BSC J
K811204 · Shiley, Inc. · May 1981
BUCKBERG-SHILEY BLOOD CARDIOPLEGIC SPL.
K802879 · Shiley, Inc. · Dec 1980