Cleared Traditional

K833555 - LAL TEST RELEASE & BONCHEK CAR/JACKET

K833555 is an FDA 510(k) clearance for LAL TEST RELEASE & BONCHEK CAR/JACKET, 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 110-day FDA review.

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

FDA 510(k) Submission Details - K833555

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.

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 K833555.
PATIENT MONITOR MODEL RM-300
K850794 · Honeywell, Inc. · Apr 1985
CARDIOPLEGIA HEAT EXCHANGER HOLDER
K840256 · American Bentley · Feb 1984
CARDIOPLEGIA HEAT EXCHANGER HE-100
K840045 · American Bentley · Feb 1984
CARDIOPLEGIA SYSTEM CCS-XXX SERIES
K833662 · Gish Biomedical, Inc. · Dec 1983
HYPOTHERMIC MYCARDIAL PROTECTION DEV
K832417 · 3M Health Care, Sarns · Oct 1983
BLOOD CARDIOPLEGIA STAINLESS STEEL COOL
K831157 · American Bentley · May 1983