Cleared Traditional

K831895 - BLOOD OXYGENATOR 50 70/S

K831895 is an FDA 510(k) clearance for BLOOD OXYGENATOR 50 70/S, manufactured by Shiley, Inc.. The device is a Class 2 Cardiovascular device with product code DTZ cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K831895 · Shiley, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1983
Decision
127d
Days
Class 2
Risk

K831895 is an FDA 510(k) clearance for the BLOOD OXYGENATOR 50 70/S. Classified as Oxygenator, Cardiopulmonary Bypass (product code DTZ), Class II - Special Controls.

Submitted by Shiley, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 19, 1983 after a review of 127 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4350 - 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 - K831895

510(k) Number K831895 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1983
Decision Date October 19, 1983
Days to Decision 127 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
2d slower than avg
Panel avg: 125d · This submission: 127d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTZ Device Classification - Class 2, Special Controls

Product Code DTZ Oxygenator, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4350
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 - DTZ Oxygenator, Cardiopulmonary Bypass

All 202
Devices cleared under the same product code (DTZ) and FDA review panel - the closest regulatory comparables to K831895.
BLOOD OXYGENATOR HEAT EXHANGER COATING
K833518 · American Bentley · Dec 1983
SHILEY M2000 MEMBRANE OXYGENATOR
K833253 · Shiley, Inc. · Dec 1983
BLOOD OXYGENATOR 5070
K831894 · Shiley, Inc. · Oct 1983
WM. HARVEY PARALLEL PLATE MEMBRANE BLOOD
K831705 · C.R. Bard, Inc. · Jul 1983
HI FLEX D-700 MODULAR BUBBLE OXYGENA-
K830639 · Electromedics, Inc. · May 1983
WILLIAM HARVEY H-1700 ADULT BLOOD OXYG-
K831122 · C.R. Bard, Inc. · May 1983