Cleared Traditional

K810470 - SHILEY S-100A (ADULT) BLOOD OXYGENATOR

K810470 is an FDA 510(k) clearance for SHILEY S-100A (ADULT) BLOOD OXYGENATOR, 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 53-day FDA review.

K810470 · Shiley, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1981
Decision
53d
Days
Class 2
Risk

K810470 is an FDA 510(k) clearance for the SHILEY S-100A (ADULT) BLOOD OXYGENATOR. 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 April 17, 1981 after a review of 53 days - a notably fast clearance cycle.

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: 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

FDA 510(k) Submission Details - K810470

510(k) Number K810470 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 1981
Decision Date April 17, 1981
Days to Decision 53 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
72d faster than avg
Panel avg: 125d · This submission: 53d
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 K810470.
MANIFOLD
K811004 · American Pharmaseal Div. Ahsc · May 1981
CARDIOPULMONARY BYPASS OXYGENATOR
K810505 · Cobe Laboratories, Inc. · Apr 1981
DISPOSABLE STOPCOCK
K810532 · Texas Medical Products, Inc. · Apr 1981
TERUMO HOLLOW FIBER OXYGENATOR
K802970 · Terumo America, Inc. · Jan 1981
INTERPULSE MEMBRANE OXYGENATION SYSTEM
K803003 · Extracorporeal Medical Specialities, Inc. · Jan 1981
THB 6000 HARDSHELL BUBBLE OXYGENATOR
K803231 · Travenol Laboratories, S.A. · Jan 1981